Conductive Hearing Loss, Deafness; Sensoneural Single Sided, Mixed Hearing Loss
Conditions
Brief summary
To study the initial experience with implanting and fitting the new Bone conduction system in patients with conductive, mixed or Single sided Sensorineural deafness.
Interventions
DEVICEOsia System
An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.
Sponsors
Cochlear
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult subjects (18 years or older) * Subject with conductive or mixed hearing loss in the ear to be implanted. Bone conduction thresholds with pure tone average (PTA4; mean of 0.5, 1, 2 and 4 kHz) of 55 dB HL. OR Subject with single-sided sensorineural deafness who is a candidate for Baha surgery. Air conduction thresholds with a pure tone average PTA4 of 20 dB HL (mean of 0.5, 1, 2 and 3 kHz) in the good ear OR subject who is indicated for an AC CROS but-for some reason-cannot or will not use an AC CROS (Air Conduction-Contralateral Routing of Signal). * Signed informed consent * Previous experience from amplified sound though a non-surgical solution. (For example but not limited to Hearing aid, CROS device, Bone conductional hearing device on headband/ softband)
Exclusion criteria
* Uncontrolled diabetes as judged by the investigator. * Condition that could jeopardise osseointegration and/or wound healing (e.g. osteoporosis, psoriasis, long-term systemic use of corticosteroids) or condition that may have an impact on the outcome of the investigation as judged by the investigator. * Insufficient bone quality and quantity for implantation of a BI300 Implant. * Subject that has received radiotherapy in the area of implantation, or is planned for such radiotherapy during the study period * Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator * Unable to follow investigational procedures, e.g. to complete quality of life scales. * Participation in another clinical investigation with pharmaceutical and/or device.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hearing Performance: Threshold Audiometry, Pure Tone Average of 4 Frequencies, PTA4, Unaided Versus OSIA System at 3 Months | Baseline before surgery, 3 months after surgery | The change of hearing performance from the unaided hearing situation before surgery to the aided hearing situation with the OSIA system at 3 month, measured as free-field hearing test; Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz) is presented. A Pure Tone Average (PTA) refers to the average of hearing threshold levels at a set of specified frequencies: typically 500, 1000, 2000 and 4000 Hz. This value gives a snapshot of an individual's hearing level. If PTA is \<25 dB, the overall hearing would be considered to be within normal limits. With a PTA of 95 dB, the hearing would be considered in the profound range. The units reported for PTA4 are decibels (dB). The results presented here are the difference of PTA4 unaided and PTA4 aided with the Osia system. An uaided PTA4 values should be higher than a aided PTA4 if the hearing device is effective. A lower or more negative score is more desirable and reflects a better ability to hear softer sounds. |
| Adaptive Speech Recognition in Noise, Unaided Versus OSIA System at 3 Months. | Baseline before surgery, 3 months after surgery | The change of hearing performance from the unaided hearing situation before surgery to the aided hearing situation with the OSIA System at 3 months measured as free field hearing test Adaptive speech recognition in noise, is presented. Adaptive speech recognition in noise was measured as Signal to Noise Ratio (SNR). The noise was kept constant at 65 dB SPL and the speech was adapted in dB steps to establish the Speech-to-Noise Ratio (SNR) providing a 50% level of understanding. A ratio of 0 reflects the ability to correctly hear sentences at 65 dB, in the presence of 65 dB background noise. A negative SNR-value reflects the ability to correctly hear sentences below 65 dB, for example if 50% of the speech is received correctly at 55 dB the SNR value is -10. A positive SNR-value (Speech to Noise Ratio) reflects the ability to correctly hear sentences presented above 65 dB. A lower or more negative score is more desirable and reflects abetter hearing in a noisy enviroment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hearing Performance: Threshold Audiometry, Pure Tone Average, PTA4, Unaided Versus OSIA System at 4 Weeks, 6 and 12 Months | Baseline before surgery, 4 weeks, 6 and 12 months after surgery | The change of hearing performance from the unaided hearinhg situation before surgery to the aided hearing situation with the OSIA system at 4 weeks, 6 and 12 months, measured as free-field hearing test: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz) is presented. A Pure Tone Average (PTA) refers to the average of hearing threshold levels at a set of specified frequencies: typically 500, 1000, 2000 and 4000 Hz. This value gives a snapshot of an individual's hearing level. If PTA is \<25 dB, the overall hearing would be considered to be within normal limits. With a PTA of 95 dB, the hearing would be considered in the profound range. The units reported for PTA4 are decibels (dB). The results presented here are the difference of PTA4 unaided and PTA4 aided with the Osia system. An uaided PTA4 values should be higher than a aided PTA4 if the hearing device is effective. A lower or more negative score is more desirable and reflects a better ability to hear softer sounds. |
| Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery. | The change of hearing performance from the unaided hearing situation before surgery to the aided hearing situation with the OSIA system at 4 weeks, 3, 6 and 12 months, measured as free-field hearing test: Threshold audiometry (0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz) is presented. This value gives a snapshot of an individual's hearing level. If PTA is \<25 dB, the overall hearing would be considered to be within normal limits. With a PTA of 95 dB, the hearing would be considered in the profound range. The units reported for PTA4 are decibels (dB). The results presented here are the difference of the unaided hearing level expressed in dB and the hearing level aided with the Osia system at different time points. An unaided value should be higher than a aided if the hearing device is effective. A lower or more negative score is therefor more desirable and reflects a better ability to hear at the specified frequency. |
| Adaptive Speech Recognition in Noise, Unaided Versus OSIA System at 4 Weeks, 6 and 12 Months | Baseline before surgery, 4 weeks, 6 and 12 months after surgery | The change of hearing performance from the unaided hearing situation before surgery to the aided hearing situation with the OSIA System at 3 months measured as free field hearing test Adaptive speech recognition in noise, is presented. Adaptive speech recognition in noise was measured as Signal to Noise Ratio (SNR). The noise was kept constant at 65 dB SPL and the speech was adapted in dB steps to establish the Speech-to-Noise Ratio (SNR) providing a 50% level of understanding. A ratio of 0 reflects the ability to correctly hear sentences at 65 dB, in the presence of 65 dB background noise. A negative SNR-value reflects the ability to correctly hear sentences below 65 dB, for example if 50% of the speech is received correctly at 55 dB the SNR value is -10. A positive SNR-value (Speech to Noise Ratio) reflects the ability to correctly hear sentences presented above 65 dB. A lower or more negative score is more desirable and reflects a better hearing in a noisy environment. |
| Abbreviated Profile of Hearing Aid Benefit (APHAB) at 3 and 12 Months | Baseline before surgery, 3 and 12 months after surgery | The change of Ease of communication, Reverberation, Background noise, Aversiveness and a Global score from the unaided hearing situation before surgery to the aided hearing situation with the OSIA System at 3 and 12 months is presented. All subscales range from 0-100%, total score is the average of all subscales 0-100%, where 0% indicates no problem and 100% indicates always problem. The difference between the unaided and the aided situation is presented. In an ultimate case the unaided value could be 100 and the aided 0, the result is then 100. A positive value indicates an improvement, a negative value an impairment. |
| Health Utility Index (HUI) at 3 and 12 Months | Baseline before surgery and 3 and 12 months after surgery | The change of health status and health related quality of life from the unaided hearing situation before surgery to the aided hearing situation with the OSIA System at 3 and 12 months using the generic quality of life scale Health Utilities Index (HUI3) is presented. All subscales (comprehensive health state, vision, hearing, speech, ambulation, dexterity, emotion, pain, cognition) range from 0-1. A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The difference between the unaided and the aided situation is presented. In an ultimate case the unaided value could be 0 and the aided 1, the result is then 1.0. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life. |
| Speech, Spatial and Qualities of Hearing Scale (SSQ) at 3 and 12 Months | Baseline before surgery and 3 and 12 months after surgery | The change of speech, spatial and hearing experiences from the unaided hearing situation before surgery to the aided hearing situation with the OSIA System at 3 and 12 months using the SSQ scale is presented. All subscales (speech, spatial, quality) range from 0 to 10, where 0 represents can not hear at all, and 10 hear perfectly. Total score is a average of the subscales. A positive value indicates improved hearing, a negative value indicates impaired hearing. |
| Hearing Performance: Threshold Audiometry PTA4, With Reference Device BP110 | Baseline before surgery, 4 weeks, 3, 6 and 12 months. | The change of hearing performance with the OSIA System at 4 weeks, 3, 6 and 12 months compared to the pre-operative aided situation with BP110 on softband, measured as free-field hearing test; Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz) is presented. The units reported for PTA4 are decibels (dB). A lower or more negative score is more desirable and reflects a better ability to hear softer sounds. |
| Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110 | Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery. | The change of hearing performance with the OSIA System at 4 weeks, 3, 6 and 12 months compared to the pre-operative aided situation with BP110 on softband, measured as free-field hearing test; Threshold audiometry individual frequencies (0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz) is presented. The units reported are decibels (dB). A lower or more negative score is more desirable and reflects a better ability to hear softer sounds. |
| Speech in Quiet at 50, 65 and 80 dB SPL, With Reference Device BP110 | Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery. | The change of hearing performance with the OSIA System at 4 weeks, 3, 6 and 12 months compared to the pre-operative aided situation with BP110 on softband measured as free-field hearing test; Speech in quiet \[% correctly perceived words at 50, 65 and 80 dB SPL\]. The change in percent points is presented. A positive value indicates an improved ability to perceive words in quiet at the specified decibel (dB) level a negative value represent an impairment. |
| Adaptive Speech Recognition in Noise, With Reference Device BP110 | Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery. | The change of hearing performance with the OSIA System at 4 weeks, 3, 6 and 12 months compared to the pre-operative aided situation with BP110 on softband;measured with free field hearing test Adaptive speech recognition in noise which was measured as signal to noise ratio (SNR). The noise was kept constant at 65 dB SPL and the speech was adapted in dB steps to establish the speech-to-noise ratio (SNR) providing a 50% level of understanding. A ratio of 0 reflects the ability to correctly hear sentences at 65 dB, in the presence of 65 dB background noise. A negative SNR-value reflects the ability to correctly hear sentences below 65 dB. A positive SNR-value reflects the ability to correctly hear sentences presented above 65 dB. A lower or more negative score is more desirable and represent a better hearing in a noisy environment. |
| Daily Usage Time of Sound Processor | 6 weeks, 3, 6 and 12 months | Sound processor usage time measured as hours per day. |
| Soft Tissue Thickness | Visit 2, surgery | Surgical information: Soft tissue thickness was measured in mm |
| Soft Tissue Reduction | Visit 2, surgery | Surgical information: a question was asked if soft tissue reduction had been performed. Could be answered by ticking a box for Yes or No. |
| Bone Polishing/Removal at Implant Site | Visit 2, surgery | Surgical information: a question is asked if bone polishing/removal at Implant site has been performed. Yes or No can be ticked. |
| Type of Anaesthesia | Visit 2, surgery | Surgical information: a question is asked which type of anaesthesia has been used: local or general can be ticked. |
| Location of BI300 Implant | Visit 2, surgery | Surgical information: where is the location of the BI300 implant, measured in two different ways: Alternative 1 used for the first 6 subjects: Location from the ear channel in mm. Alternative 2 used for the rest of the population 45 subjects, after an amendment: measured in mm horizontally and vertically from ear channel. and the distance in mm between the receiver and the coil. Value 9.64 mm vertically from ear channel is correct. |
| Incision Type | Visit 2, surgery | Surgical information: a question was asked regarding what type of incision had been used; C-shaped flap, posterior based flap or other could be ticked. |
| Comfort | 6 weeks, 3, 6 and 12 months | Comfort of sound processor measured with a visual analogue scale where 0% is defined as no comfort at all and 100% as most comfortable imaginable, i.e. minimum 0, maximum 100. |
| Magnet Choice | 4, 6 weeks, 3, 6 and 12 months | Available magnet strengths: 1/2, 1, 2, 3, 4, 5 or 6, where 1/2 is the weakest and 6 the strongest. |
| Softpad Use | 6 weeks, 3, 6 and 12 months | A question was asked if the subjects used softpads; yes or no could be ticked. |
| Surgical Information: Time of Surgery | Visit 2, surgery | Surgery time in minutes between first incision and last suture |
| Speech in Quiet at 50, 65 and 80 dB SPL, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery. | The change of hearing performance from the unaided hearing situation before surgery to the aided hearing situation with the OSIA System at 4 weeks, 3, 6 and 12 months, measured as free-field hearing test Speech in quiet at 50, 65 and 80 dB SPL \[% correctly perceived words at 50, 65 and 80 dB SPL\] is presented. The change in percent points is presented. A positive value indicates an improved ability to perceive words in quiet at the specified decibel (dB) level a negative value represent an impairment. |
Countries
Australia, Germany, Netherlands, Poland, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bone-conduction Hearing Device The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.
Osia System: An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea. | 51 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Bone-conduction Hearing Device |
|---|---|
| Age, Continuous | 47.4 years STANDARD_DEVIATION 14.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 51 Participants |
| Region of Enrollment Australia | 12 participants |
| Region of Enrollment Germany | 10 participants |
| Region of Enrollment Netherlands | 9 participants |
| Region of Enrollment Poland | 10 participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 51 |
| other Total, other adverse events | 42 / 51 |
| serious Total, serious adverse events | 2 / 51 |
Outcome results
Primary
Adaptive Speech Recognition in Noise, Unaided Versus OSIA System at 3 Months.
The change of hearing performance from the unaided hearing situation before surgery to the aided hearing situation with the OSIA System at 3 months measured as free field hearing test Adaptive speech recognition in noise, is presented. Adaptive speech recognition in noise was measured as Signal to Noise Ratio (SNR). The noise was kept constant at 65 dB SPL and the speech was adapted in dB steps to establish the Speech-to-Noise Ratio (SNR) providing a 50% level of understanding. A ratio of 0 reflects the ability to correctly hear sentences at 65 dB, in the presence of 65 dB background noise. A negative SNR-value reflects the ability to correctly hear sentences below 65 dB, for example if 50% of the speech is received correctly at 55 dB the SNR value is -10. A positive SNR-value (Speech to Noise Ratio) reflects the ability to correctly hear sentences presented above 65 dB. A lower or more negative score is more desirable and reflects abetter hearing in a noisy enviroment.
Time frame: Baseline before surgery, 3 months after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone-conduction Hearing Device | Adaptive Speech Recognition in Noise, Unaided Versus OSIA System at 3 Months. | -13.3 SNR (Speech in Noise Ratio) | Standard Deviation 8.3 |
Comparison: Speech in noise at 3 months with the Osia system vs Unaided at visit 1p-value: <0.0001Fisher's non-parametric permutation test
Primary
Hearing Performance: Threshold Audiometry, Pure Tone Average of 4 Frequencies, PTA4, Unaided Versus OSIA System at 3 Months
The change of hearing performance from the unaided hearing situation before surgery to the aided hearing situation with the OSIA system at 3 month, measured as free-field hearing test; Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz) is presented. A Pure Tone Average (PTA) refers to the average of hearing threshold levels at a set of specified frequencies: typically 500, 1000, 2000 and 4000 Hz. This value gives a snapshot of an individual's hearing level. If PTA is \<25 dB, the overall hearing would be considered to be within normal limits. With a PTA of 95 dB, the hearing would be considered in the profound range. The units reported for PTA4 are decibels (dB). The results presented here are the difference of PTA4 unaided and PTA4 aided with the Osia system. An uaided PTA4 values should be higher than a aided PTA4 if the hearing device is effective. A lower or more negative score is more desirable and reflects a better ability to hear softer sounds.
Time frame: Baseline before surgery, 3 months after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry, Pure Tone Average of 4 Frequencies, PTA4, Unaided Versus OSIA System at 3 Months | -25.8 dB (Decibel) | Standard Deviation 9.1 |
Comparison: PTA4 at 3 months with the Osia system vs Unaided at visit 1p-value: <0.0001Fisher's non-parametric permutation test
Secondary
Abbreviated Profile of Hearing Aid Benefit (APHAB) at 3 and 12 Months
The change of Ease of communication, Reverberation, Background noise, Aversiveness and a Global score from the unaided hearing situation before surgery to the aided hearing situation with the OSIA System at 3 and 12 months is presented. All subscales range from 0-100%, total score is the average of all subscales 0-100%, where 0% indicates no problem and 100% indicates always problem. The difference between the unaided and the aided situation is presented. In an ultimate case the unaided value could be 100 and the aided 0, the result is then 100. A positive value indicates an improvement, a negative value an impairment.
Time frame: Baseline before surgery, 3 and 12 months after surgery
Population: Some of the subjects did not answer some of the questions at one or more visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bone-conduction Hearing Device | Abbreviated Profile of Hearing Aid Benefit (APHAB) at 3 and 12 Months | 3 months: Ease of communication | 24.1 units on a scale | Standard Deviation 21.7 |
| Bone-conduction Hearing Device | Abbreviated Profile of Hearing Aid Benefit (APHAB) at 3 and 12 Months | 3 months: Background noise | 29.4 units on a scale | Standard Deviation 20 |
| Bone-conduction Hearing Device | Abbreviated Profile of Hearing Aid Benefit (APHAB) at 3 and 12 Months | 3 months: Reverberation | 25.8 units on a scale | Standard Deviation 23.1 |
| Bone-conduction Hearing Device | Abbreviated Profile of Hearing Aid Benefit (APHAB) at 3 and 12 Months | 3 months: Aversiveness | -2.2 units on a scale | Standard Deviation 22.3 |
| Bone-conduction Hearing Device | Abbreviated Profile of Hearing Aid Benefit (APHAB) at 3 and 12 Months | 3 months: Global | 26.1 units on a scale | Standard Deviation 18.5 |
| Bone-conduction Hearing Device | Abbreviated Profile of Hearing Aid Benefit (APHAB) at 3 and 12 Months | 12 months: Ease of communication | 24.0 units on a scale | Standard Deviation 19.1 |
| Bone-conduction Hearing Device | Abbreviated Profile of Hearing Aid Benefit (APHAB) at 3 and 12 Months | 12 months: Background noise | 29.6 units on a scale | Standard Deviation 20.9 |
| Bone-conduction Hearing Device | Abbreviated Profile of Hearing Aid Benefit (APHAB) at 3 and 12 Months | 12 months: Reverberation | 25.4 units on a scale | Standard Deviation 25.8 |
| Bone-conduction Hearing Device | Abbreviated Profile of Hearing Aid Benefit (APHAB) at 3 and 12 Months | 12 months: Aversiveness | -3.58 units on a scale | Standard Deviation 24.6 |
| Bone-conduction Hearing Device | Abbreviated Profile of Hearing Aid Benefit (APHAB) at 3 and 12 Months | 12 months: Global | 26.3 units on a scale | Standard Deviation 18.5 |
Comparison: APHAB, Ease of communication, at 3 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: APHAB, Background noise, at 3 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: APHAB, Reverberation, at 3 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: APHAB, Aversiveness, at 3 months with the Osia system vs Unaided at visit 1.p-value: 0.51Fisher's non-parametric permutation test
Comparison: APHAB, Global score, at 3 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: APHAB, Ease of communication, at 12 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: APHAB, Background noise, at 12 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: APHAB, Reverberation, at 12 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: APHAB, Aversiveness, at 12 months with the Osia system vs Unaided at visit 1.p-value: 0.32Fisher's non-parametric permutation test
Comparison: APHAB, Global score, at 12 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Secondary
Adaptive Speech Recognition in Noise, Unaided Versus OSIA System at 4 Weeks, 6 and 12 Months
The change of hearing performance from the unaided hearing situation before surgery to the aided hearing situation with the OSIA System at 3 months measured as free field hearing test Adaptive speech recognition in noise, is presented. Adaptive speech recognition in noise was measured as Signal to Noise Ratio (SNR). The noise was kept constant at 65 dB SPL and the speech was adapted in dB steps to establish the Speech-to-Noise Ratio (SNR) providing a 50% level of understanding. A ratio of 0 reflects the ability to correctly hear sentences at 65 dB, in the presence of 65 dB background noise. A negative SNR-value reflects the ability to correctly hear sentences below 65 dB, for example if 50% of the speech is received correctly at 55 dB the SNR value is -10. A positive SNR-value (Speech to Noise Ratio) reflects the ability to correctly hear sentences presented above 65 dB. A lower or more negative score is more desirable and reflects a better hearing in a noisy environment.
Time frame: Baseline before surgery, 4 weeks, 6 and 12 months after surgery
Population: Some subjects did not perform the test at one or more visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bone-conduction Hearing Device | Adaptive Speech Recognition in Noise, Unaided Versus OSIA System at 4 Weeks, 6 and 12 Months | 4 weeks | -12.1 SNR (Speech in Noise Ratio) | Standard Deviation 8.1 |
| Bone-conduction Hearing Device | Adaptive Speech Recognition in Noise, Unaided Versus OSIA System at 4 Weeks, 6 and 12 Months | 6 months | -13.7 SNR (Speech in Noise Ratio) | Standard Deviation 8.1 |
| Bone-conduction Hearing Device | Adaptive Speech Recognition in Noise, Unaided Versus OSIA System at 4 Weeks, 6 and 12 Months | 12 months | -13.6 SNR (Speech in Noise Ratio) | Standard Deviation 8.8 |
Comparison: Adaptive speech recognition in noise at 4 weeks with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Adaptive speech recognition in noise at 6 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Adaptive speech recognition in noise at 12 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Secondary
Adaptive Speech Recognition in Noise, With Reference Device BP110
The change of hearing performance with the OSIA System at 4 weeks, 3, 6 and 12 months compared to the pre-operative aided situation with BP110 on softband;measured with free field hearing test Adaptive speech recognition in noise which was measured as signal to noise ratio (SNR). The noise was kept constant at 65 dB SPL and the speech was adapted in dB steps to establish the speech-to-noise ratio (SNR) providing a 50% level of understanding. A ratio of 0 reflects the ability to correctly hear sentences at 65 dB, in the presence of 65 dB background noise. A negative SNR-value reflects the ability to correctly hear sentences below 65 dB. A positive SNR-value reflects the ability to correctly hear sentences presented above 65 dB. A lower or more negative score is more desirable and represent a better hearing in a noisy environment.
Time frame: Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.
Population: Some of the subjects did not perform the test at all visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bone-conduction Hearing Device | Adaptive Speech Recognition in Noise, With Reference Device BP110 | 4 weeks | -6.12 SNR | Standard Deviation 6.92 |
| Bone-conduction Hearing Device | Adaptive Speech Recognition in Noise, With Reference Device BP110 | 3 months | -7.19 SNR | Standard Deviation 6.8 |
| Bone-conduction Hearing Device | Adaptive Speech Recognition in Noise, With Reference Device BP110 | 6 months | -7.91 SNR | Standard Deviation 6.8 |
| Bone-conduction Hearing Device | Adaptive Speech Recognition in Noise, With Reference Device BP110 | 12 months | -7.54 SNR | Standard Deviation 7.99 |
Comparison: Adaptive Speech Recognition in Noise with Osia at 4 weeks vs reference device BP110 on softband at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Adaptive Speech Recognition in Noise with Osia at 3 months vs reference device BP110 on softband at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Adaptive Speech Recognition in Noise with Osia at 6 months vs reference device BP110 on softband at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Adaptive Speech Recognition in Noise with Osia at 12 months vs reference device BP110 on softband at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Secondary
Bone Polishing/Removal at Implant Site
Surgical information: a question is asked if bone polishing/removal at Implant site has been performed. Yes or No can be ticked.
Time frame: Visit 2, surgery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bone-conduction Hearing Device | Bone Polishing/Removal at Implant Site | Yes | 42 Participants |
| Bone-conduction Hearing Device | Bone Polishing/Removal at Implant Site | No | 9 Participants |
Secondary
Comfort
Comfort of sound processor measured with a visual analogue scale where 0% is defined as no comfort at all and 100% as most comfortable imaginable, i.e. minimum 0, maximum 100.
Time frame: 6 weeks, 3, 6 and 12 months
Population: Some of the subjects did not answer the question at all visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bone-conduction Hearing Device | Comfort | 6 weeks | 77.3 units on a scale | Standard Deviation 18.6 |
| Bone-conduction Hearing Device | Comfort | 3 months | 80.8 units on a scale | Standard Deviation 16.6 |
| Bone-conduction Hearing Device | Comfort | 6 months | 78.2 units on a scale | Standard Deviation 20.1 |
| Bone-conduction Hearing Device | Comfort | 12 months | 80.9 units on a scale | Standard Deviation 16.2 |
Secondary
Daily Usage Time of Sound Processor
Sound processor usage time measured as hours per day.
Time frame: 6 weeks, 3, 6 and 12 months
Population: Some of the subjects did not answer the question at all visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bone-conduction Hearing Device | Daily Usage Time of Sound Processor | 6 weeks | 10.7 hours per day | Standard Deviation 3.8 |
| Bone-conduction Hearing Device | Daily Usage Time of Sound Processor | 3 months | 10.5 hours per day | Standard Deviation 4.3 |
| Bone-conduction Hearing Device | Daily Usage Time of Sound Processor | 6 months | 10.6 hours per day | Standard Deviation 4.6 |
| Bone-conduction Hearing Device | Daily Usage Time of Sound Processor | 12 months | 11.3 hours per day | Standard Deviation 3.6 |
Secondary
Health Utility Index (HUI) at 3 and 12 Months
The change of health status and health related quality of life from the unaided hearing situation before surgery to the aided hearing situation with the OSIA System at 3 and 12 months using the generic quality of life scale Health Utilities Index (HUI3) is presented. All subscales (comprehensive health state, vision, hearing, speech, ambulation, dexterity, emotion, pain, cognition) range from 0-1. A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The difference between the unaided and the aided situation is presented. In an ultimate case the unaided value could be 0 and the aided 1, the result is then 1.0. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life.
Time frame: Baseline before surgery and 3 and 12 months after surgery
Population: Some of the subjects did not answer all questions in the questionnaire at one or both time-points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bone-conduction Hearing Device | Health Utility Index (HUI) at 3 and 12 Months | 3 months: Pain | 0.007 units on a scale | Standard Deviation 0.258 |
| Bone-conduction Hearing Device | Health Utility Index (HUI) at 3 and 12 Months | 12 months: comprehensive health state | 0.058 units on a scale | Standard Deviation 0.243 |
| Bone-conduction Hearing Device | Health Utility Index (HUI) at 3 and 12 Months | 12 months: Vision | -0.011 units on a scale | Standard Deviation 0.055 |
| Bone-conduction Hearing Device | Health Utility Index (HUI) at 3 and 12 Months | 12 months: Hearing | 0.149 units on a scale | Standard Deviation 0.3 |
| Bone-conduction Hearing Device | Health Utility Index (HUI) at 3 and 12 Months | 12 months: Speech | 0.062 units on a scale | Standard Deviation 0.136 |
| Bone-conduction Hearing Device | Health Utility Index (HUI) at 3 and 12 Months | 12 months: Ambulation | -0.024 units on a scale | Standard Deviation 0.094 |
| Bone-conduction Hearing Device | Health Utility Index (HUI) at 3 and 12 Months | 12 months: Dexterity | -0.011 units on a scale | Standard Deviation 0.122 |
| Bone-conduction Hearing Device | Health Utility Index (HUI) at 3 and 12 Months | 12 months: Emotion | 0.004 units on a scale | Standard Deviation 0.144 |
| Bone-conduction Hearing Device | Health Utility Index (HUI) at 3 and 12 Months | 12 months: Cognition | 0.001 units on a scale | Standard Deviation 0.125 |
| Bone-conduction Hearing Device | Health Utility Index (HUI) at 3 and 12 Months | 12 months: Pain | -0.029 units on a scale | Standard Deviation 0.334 |
| Bone-conduction Hearing Device | Health Utility Index (HUI) at 3 and 12 Months | 3 months: comprehensive health state | 0.081 units on a scale | Standard Deviation 0.227 |
| Bone-conduction Hearing Device | Health Utility Index (HUI) at 3 and 12 Months | 3 months: Vision | -0.006 units on a scale | Standard Deviation 0.035 |
| Bone-conduction Hearing Device | Health Utility Index (HUI) at 3 and 12 Months | 3 months: Hearing | 0.173 units on a scale | Standard Deviation 0.324 |
| Bone-conduction Hearing Device | Health Utility Index (HUI) at 3 and 12 Months | 3 months: Speech | 0.033 units on a scale | Standard Deviation 0.129 |
| Bone-conduction Hearing Device | Health Utility Index (HUI) at 3 and 12 Months | 3 months: Ambulation | -0.018 units on a scale | Standard Deviation 0.063 |
| Bone-conduction Hearing Device | Health Utility Index (HUI) at 3 and 12 Months | 3 months: Dexterity | 0.000 units on a scale | Standard Deviation 0 |
| Bone-conduction Hearing Device | Health Utility Index (HUI) at 3 and 12 Months | 3 months: Emotion | 0.016 units on a scale | Standard Deviation 0.12 |
| Bone-conduction Hearing Device | Health Utility Index (HUI) at 3 and 12 Months | 3 months: Cognition | 0.013 units on a scale | Standard Deviation 0.088 |
Comparison: HUI Comprehensive health state at 3 months with the Osia system vs Unaided at visit 1.p-value: 0.026Fisher's non-parametric permutation test
Comparison: HUI Vision attribute at 3 months with the Osia system vs Unaided at visit 1.p-value: 0.5Fisher's non-parametric permutation test
Comparison: HUI Hearing attribute, at 3 months with the Osia system vs Unaided at visit 1.p-value: 0.0008Fisher's non-parametric permutation test
Comparison: HUI Speech attribute, at 3 months with the Osia system vs Unaided at visit 1.p-value: 0.082Fisher's non-parametric permutation test
Comparison: HUI Ambulation attribute, at 3 months with the Osia system vs Unaided at visit 1.p-value: 0.13Fisher's non-parametric permutation test
Comparison: HUI Dexterity attribute, at 3 months with the Osia system vs Unaided at visit 1.p-value: 0.9Wilcoxon Signed Rank test
Comparison: HUI Emotion attribute, at 3 months with the Osia system vs Unaided at visit 1.p-value: 0.43Fisher's non-parametric permutation test
Comparison: HUI Cognition attribute, at 3 months with the Osia system vs Unaided at visit 1.p-value: 0.31Fisher's non-parametric permutation test
Comparison: HUI Pain attribute, at 3 months with the Osia system vs Unaided at visit 1.p-value: 0.72Wilcoxon Signed Rank test
Comparison: HUI Comprehensive Health State attribute, at 12 months with the Osia system vs Unaided at visit 1.p-value: 0.13Fisher's non-parametric permutation test
Comparison: HUI Vision attribute, at 12 months with the Osia system vs Unaided at visit 1.p-value: 0.23Wilcoxon Signed Rank test
Comparison: HUI Hearing attribute, at 12 months with the Osia system vs Unaided at visit 1.p-value: 0.0026Fisher's non-parametric permutation test
Comparison: HUI Speech attribute, at 12 months with the Osia system vs Unaided at visit 1.p-value: 0.0024Fisher's non-parametric permutation test
Comparison: HUI Ambulation attribute, at 12 months with the Osia system vs Unaided at visit 1.p-value: 0.16Fisher's non-parametric permutation test
Comparison: HUI Dexterity attribute, at 12 months with the Osia system vs Unaided at visit 1.p-value: 0.16Fisher's non-parametric permutation test
Comparison: HUI Emotion attribute, at 12 months with the Osia system vs Unaided at visit 1.p-value: 0.85Fisher's non-parametric permutation test
Comparison: HUI Cognition attribute, at 12 months with the Osia system vs Unaided at visit 1.p-value: 1Fisher's non-parametric permutation test
Comparison: HUI Pain attribute, at 12 months with the Osia system vs Unaided at visit 1.p-value: 0.56Fisher's non-parametric permutation test
Secondary
Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
The change of hearing performance from the unaided hearing situation before surgery to the aided hearing situation with the OSIA system at 4 weeks, 3, 6 and 12 months, measured as free-field hearing test: Threshold audiometry (0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz) is presented. This value gives a snapshot of an individual's hearing level. If PTA is \<25 dB, the overall hearing would be considered to be within normal limits. With a PTA of 95 dB, the hearing would be considered in the profound range. The units reported for PTA4 are decibels (dB). The results presented here are the difference of the unaided hearing level expressed in dB and the hearing level aided with the Osia system at different time points. An unaided value should be higher than a aided if the hearing device is effective. A lower or more negative score is therefor more desirable and reflects a better ability to hear at the specified frequency.
Time frame: Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.
Population: 750, 1500 and 8000 Hz were not included in the eCRF for free-field threshold audiometry test due to an error when the first six subjects entered the study. Measurements at these frequencies were therefore not performed at the first visits. In addition; not all subjects performed the test at all frequencies at all visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 4 weeks: 250 Hz | -10.3 dB (Decibel) | Standard Deviation 12.9 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 4 weeks: 500 Hz | -23.3 dB (Decibel) | Standard Deviation 11.1 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 4 weeks: 750 Hz | -28.3 dB (Decibel) | Standard Deviation 12.1 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 4 weeks: 1000 Hz | -26.4 dB (Decibel) | Standard Deviation 11.2 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 4 weeks: 1500 Hz | -24.2 dB (Decibel) | Standard Deviation 12.1 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 4 weeks: 2000 Hz | -23.8 dB (Decibel) | Standard Deviation 11.5 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 4 weeks: 3000 Hz | -24.7 dB (Decibel) | Standard Deviation 11.3 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 4 weeks: 4000 Hz | -26.1 dB (Decibel) | Standard Deviation 10.5 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 4 weeks: 6000 Hz | -29.6 dB (Decibel) | Standard Deviation 11.3 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 4 weeks: 8000 Hz | -29.8 dB (Decibel) | Standard Deviation 12.5 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 3 months: 250 Hz | -10.8 dB (Decibel) | Standard Deviation 13.1 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 3 months: 500 Hz | -23.9 dB (Decibel) | Standard Deviation 11.3 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 3 months: 750 Hz | -28.5 dB (Decibel) | Standard Deviation 12.1 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 3 months: 1000 Hz | -27.4 dB (Decibel) | Standard Deviation 11.9 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 3 months: 1500 Hz | -25.1 dB (Decibel) | Standard Deviation 10.6 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 3 months: 2000 Hz | -24.9 dB (Decibel) | Standard Deviation 11 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 3 months: 3000 Hz | -26.1 dB (Decibel) | Standard Deviation 10.7 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 3 months: 4000 Hz | -26.8 dB (Decibel) | Standard Deviation 10.6 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 3 months: 6000 Hz | -31.7 dB (Decibel) | Standard Deviation 11.2 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 3 months: 8000 Hz | -30.9 dB (Decibel) | Standard Deviation 13.8 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 6 months: 250 Hz | -11.9 dB (Decibel) | Standard Deviation 11.9 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 6 months: 500 Hz | -26.2 dB (Decibel) | Standard Deviation 11.3 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 6 months: 750 Hz | -30.4 dB (Decibel) | Standard Deviation 12 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 6 months: 1000 Hz | -28.9 dB (Decibel) | Standard Deviation 11.1 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 6 months: 1500 Hz | -28.0 dB (Decibel) | Standard Deviation 12.1 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 6 months: 2000 Hz | -26.1 dB (Decibel) | Standard Deviation 10.9 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 6 months: 3000 Hz | -27.6 dB (Decibel) | Standard Deviation 10.8 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 6 months: 4000 Hz | -30.2 dB (Decibel) | Standard Deviation 11.2 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 6 months: 6000 Hz | -31.6 dB (Decibel) | Standard Deviation 10.6 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 6 months: 8000 Hz | -33.7 dB (Decibel) | Standard Deviation 12.3 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 12 months: 250 Hz | -14.7 dB (Decibel) | Standard Deviation 12.8 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 12 months: 500 Hz | -27.8 dB (Decibel) | Standard Deviation 10.9 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 12 months: 750 Hz | -31.8 dB (Decibel) | Standard Deviation 11.6 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 12 months: 1000 Hz | -31.8 dB (Decibel) | Standard Deviation 10.6 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 12 months: 1500 Hz | -31.2 dB (Decibel) | Standard Deviation 12.1 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 12 months: 2000 Hz | -28.8 dB (Decibel) | Standard Deviation 11.1 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 12 months: 3000 Hz | -29.6 dB (Decibel) | Standard Deviation 12 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 12 months: 4000 Hz | -33.0 dB (Decibel) | Standard Deviation 12.2 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 12 months: 6000 Hz | -35.9 dB (Decibel) | Standard Deviation 11.6 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 12 months: 8000 Hz | -38.8 dB (Decibel) | Standard Deviation 12 |
Comparison: Threshold audiometry 250Hz at 4 weeks with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Threshold audiometry at 500Hz at 4 weeks with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Threshold audiometry at 750Hz at 4 weeks with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Threshold audiometry at 1000Hz at 4 weeks with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Threshold audiometry at 1500Hz at 4 weeks with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Threshold audiometry at 2000Hz at 4 weeks with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Threshold audiometry at 3000Hz at 4 weeks with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Threshold audiometry at 4000Hz at 4 weeks with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Threshold audiometry at 6000Hz at 4 weeks with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Threshold audiometry at 8000Hz at 4 weeks with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Threshold audiometry at 250Hz at 3 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Threshold audiometry at 500Hz at 3 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Threshold audiometry at 750Hz at 3 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Threshold audiometry at 1000Hz at 3 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Threshold audiometry at 1500Hz at 3 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Threshold audiometry at 2000Hz at 3 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Threshold audiometry at 3000Hz at 3 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Threshold audiometry at 4000Hz at 3 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Threshold audiometry at 6000Hz at 3 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Threshold audiometry at 8000Hz at 3 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Threshold audiometry at 250Hz at 6 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Threshold audiometry at 500Hz at 6 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Threshold audiometry at 750Hz at 6 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Threshold audiometry at 1000Hz at 6 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Threshold audiometry at 1500Hz at 6 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Threshold audiometry at 2000Hz at 6 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Threshold audiometry at 3000Hz at 6 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Threshold audiometry at 4000Hz at 6 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Threshold audiometry at 6000Hz at 6 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Threshold audiometry at 8000Hz at 6 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Threshold audiometry at 250Hz at 12 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Threshold audiometry at 500Hz at 12 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Threshold audiometry at 750Hz at 12 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Threshold audiometry at 1000Hz at 12 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Threshold audiometry at 1500Hz at 12 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Threshold audiometry at 2000Hz at 12 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Threshold audiometry at 3000Hz at 12 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Threshold audiometry at 4000Hz at 12 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Threshold audiometry at 6000Hz at 12 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Threshold audiometry at 8000Hz at 12 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Secondary
Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110
The change of hearing performance with the OSIA System at 4 weeks, 3, 6 and 12 months compared to the pre-operative aided situation with BP110 on softband, measured as free-field hearing test; Threshold audiometry individual frequencies (0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz) is presented. The units reported are decibels (dB). A lower or more negative score is more desirable and reflects a better ability to hear softer sounds.
Time frame: Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.
Population: Some of the subjects did not perform all measurements at all visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110 | 4 weeks: 250 hz | 3.58 dB | Standard Deviation 10.98 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110 | 4 weeks: 500 Hz | -2.22 dB | Standard Deviation 9.15 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110 | 4 weeks: 750 Hz | -3.30 dB | Standard Deviation 8.49 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110 | 4 weeks: 1000 Hz | 0.42 dB | Standard Deviation 6.65 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110 | 4 weeks: 1500 Hz | -0.48 dB | Standard Deviation 8.39 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110 | 4 weeks: 2000 Hz | -2.62 dB | Standard Deviation 7.66 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110 | 4 weeks: 3000 Hz | -3.18 dB | Standard Deviation 7.86 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110 | 4 weeks: 4000 Hz | -8.20 dB | Standard Deviation 9.58 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110 | 4 weeks: 6000 Hz | -12.5 dB | Standard Deviation 10.3 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110 | 4 weeks: 8000 Hz | -16.4 dB | Standard Deviation 17.3 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110 | 3 months: 250 Hz | 3.20 dB | Standard Deviation 9.19 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110 | 3 months: 500 Hz | -2.69 dB | Standard Deviation 8.86 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110 | 3 months: 750 Hz | -2.86 dB | Standard Deviation 8.66 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110 | 3 months: 1000 Hz | -0.47 dB | Standard Deviation 7.22 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110 | 3 months: 1500 Hz | -1.19 dB | Standard Deviation 7.82 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110 | 3 months: 2000 Hz | -3.37 dB | Standard Deviation 8.15 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110 | 3 months: 3000 Hz | -4.57 dB | Standard Deviation 9.11 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110 | 3 months: 4000 Hz | -8.73 dB | Standard Deviation 10.07 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110 | 3 months: 6000 Hz | -15.0 dB | Standard Deviation 9.9 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110 | 3 months: 8000 Hz | -18.1 dB | Standard Deviation 18.4 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110 | 6 months: 250 Hz | 2.10 dB | Standard Deviation 8.7 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110 | 6 months: 500 Hz | -4.69 dB | Standard Deviation 8.9 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110 | 6 months: 750 Hz | -4.70 dB | Standard Deviation 7.9 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110 | 6 months: 1000 Hz | -1.67 dB | Standard Deviation 7.03 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110 | 6 months: 1500 Hz | -4.00 dB | Standard Deviation 7.23 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110 | 6 months: 2000 Hz | -4.61 dB | Standard Deviation 8.29 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110 | 6 months: 3000 Hz | -5.76 dB | Standard Deviation 8.06 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110 | 6 months: 4000 Hz | -11.9 dB | Standard Deviation 10.4 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110 | 6 months: 6000 Hz | -14.4 dB | Standard Deviation 10.7 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110 | 6 months: 8000 Hz | -20.7 dB | Standard Deviation 17.6 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110 | 12 months: 250 Hz | -0.39 dB | Standard Deviation 9.81 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110 | 12 months: 500 Hz | -5.91 dB | Standard Deviation 8.79 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110 | 12 months: 750 Hz | -5.75 dB | Standard Deviation 8.65 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110 | 12 months: 1000 Hz | -4.07 dB | Standard Deviation 7.98 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110 | 12 months: 1500 Hz | -6.73 dB | Standard Deviation 8.21 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110 | 12 months: 2000 Hz | -6.80 dB | Standard Deviation 8.33 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110 | 12 months: 3000 Hz | -7.61 dB | Standard Deviation 9.13 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110 | 12 months: 4000 Hz | -14.6 dB | Standard Deviation 10.8 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110 | 12 months: 6000 Hz | -18.6 dB | Standard Deviation 11.4 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110 | 12 months: 8000 Hz | -26.5 dB | Standard Deviation 17.3 |
Comparison: Hearing performance: threshold audiometry 250Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.p-value: 0.025Fisher's non-parametric permutation test
Comparison: Hearing performance: threshold audiometry 500Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.p-value: 0.096Fisher's non-parametric permutation test
Comparison: Hearing performance: threshold audiometry 750Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.p-value: 0.015Fisher's non-parametric permutation test
Comparison: Hearing performance: threshold audiometry 1000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.p-value: 0.67Fisher's non-parametric permutation test
Comparison: Hearing performance: threshold audiometry 1500Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.p-value: 0.73Fisher's non-parametric permutation test
Comparison: Hearing performance: threshold audiometry 2000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.p-value: 0.019Fisher's non-parametric permutation test
Comparison: Hearing performance: threshold audiometry 3000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.p-value: 0.0046Fisher's non-parametric permutation test
Comparison: Hearing performance: threshold audiometry 4000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Hearing performance: threshold audiometry 6000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Hearing performance: threshold audiometry 8000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Hearing performance: threshold audiometry 250Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.p-value: 0.019Fisher's non-parametric permutation test
Comparison: Hearing performance: threshold audiometry 500Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.p-value: 0.04Fisher's non-parametric permutation test
Comparison: Hearing performance: threshold audiometry 750Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.p-value: 0.037Fisher's non-parametric permutation test
Comparison: Hearing performance: threshold audiometry 1000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.p-value: 0.67Fisher's non-parametric permutation test
Comparison: Hearing performance: threshold audiometry 1500Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.p-value: 0.34Fisher's non-parametric permutation test
Comparison: Hearing performance: threshold audiometry 2000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.p-value: 0.0048Fisher's non-parametric permutation test
Comparison: Hearing performance: threshold audiometry 3000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.p-value: 0.0008Fisher's non-parametric permutation test
Comparison: Hearing performance: threshold audiometry 4000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Hearing performance: threshold audiometry 6000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.p-value: <0.0001Wilcoxon (Mann-Whitney)
Comparison: Hearing performance: threshold audiometry 8000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Hearing performance: threshold audiometry 250Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.p-value: 0.1Fisher's non-parametric permutation test
Comparison: Hearing performance: threshold audiometry 500Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.p-value: 0.0007Fisher's non-parametric permutation test
Comparison: Hearing performance: threshold audiometry 750Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.p-value: 0.0003Fisher's non-parametric permutation test
Comparison: Hearing performance: threshold audiometry 1000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.p-value: 0.11Fisher's non-parametric permutation test
Comparison: Hearing performance: threshold audiometry 1500Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Hearing performance: threshold audiometry 2000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.p-value: 0.0001Fisher's non-parametric permutation test
Comparison: Hearing performance: threshold audiometry 3000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Hearing performance: threshold audiometry 4000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Hearing performance: threshold audiometry 6000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Hearing performance: threshold audiometry 8000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Hearing performance: threshold audiometry 250Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.p-value: 0.8Fisher's non-parametric permutation test
Comparison: Hearing performance: threshold audiometry 500Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Hearing performance: threshold audiometry 750Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Hearing performance: threshold audiometry 1000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.p-value: 0.001Fisher's non-parametric permutation test
Comparison: Hearing performance: threshold audiometry 1500Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Hearing performance: threshold audiometry 2000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Hearing performance: threshold audiometry 3000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Hearing performance: threshold audiometry 4000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Hearing performance: threshold audiometry 6000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Hearing performance: threshold audiometry 8000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Secondary
Hearing Performance: Threshold Audiometry PTA4, With Reference Device BP110
The change of hearing performance with the OSIA System at 4 weeks, 3, 6 and 12 months compared to the pre-operative aided situation with BP110 on softband, measured as free-field hearing test; Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz) is presented. The units reported for PTA4 are decibels (dB). A lower or more negative score is more desirable and reflects a better ability to hear softer sounds.
Time frame: Baseline before surgery, 4 weeks, 3, 6 and 12 months.
Population: Some of the subjects did not perform a PTA4 measurement at one or more visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry PTA4, With Reference Device BP110 | 4 weeks | -3.16 dB | Standard Deviation 5.68 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry PTA4, With Reference Device BP110 | 3 months | -3.82 dB | Standard Deviation 5.94 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry PTA4, With Reference Device BP110 | 6 months | -5.72 dB | Standard Deviation 5.84 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry PTA4, With Reference Device BP110 | 12 months | -7.85 dB | Standard Deviation 6.35 |
Comparison: Hearing performance: threshold audiometry PTA4 with Osia at 4 week vs the reference device BP110 on a softband at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Hearing performance: threshold audiometry PTA4 with Osia at 3 months vs the reference device BP110 on a softband at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Hearing performance: threshold audiometry PTA4 with Osia at 6 months vs the reference device BP110 on a softband at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Hearing performance: threshold audiometry PTA4 with Osia at 12 months vs the reference device BP110 on a softband at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Secondary
Hearing Performance: Threshold Audiometry, Pure Tone Average, PTA4, Unaided Versus OSIA System at 4 Weeks, 6 and 12 Months
The change of hearing performance from the unaided hearinhg situation before surgery to the aided hearing situation with the OSIA system at 4 weeks, 6 and 12 months, measured as free-field hearing test: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz) is presented. A Pure Tone Average (PTA) refers to the average of hearing threshold levels at a set of specified frequencies: typically 500, 1000, 2000 and 4000 Hz. This value gives a snapshot of an individual's hearing level. If PTA is \<25 dB, the overall hearing would be considered to be within normal limits. With a PTA of 95 dB, the hearing would be considered in the profound range. The units reported for PTA4 are decibels (dB). The results presented here are the difference of PTA4 unaided and PTA4 aided with the Osia system. An uaided PTA4 values should be higher than a aided PTA4 if the hearing device is effective. A lower or more negative score is more desirable and reflects a better ability to hear softer sounds.
Time frame: Baseline before surgery, 4 weeks, 6 and 12 months after surgery
Population: Some subjects did not perform the test at one or more visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry, Pure Tone Average, PTA4, Unaided Versus OSIA System at 4 Weeks, 6 and 12 Months | 4 weeks | -24.9 dB | Standard Deviation 9.4 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry, Pure Tone Average, PTA4, Unaided Versus OSIA System at 4 Weeks, 6 and 12 Months | 6 months | -27.9 dB | Standard Deviation 9.1 |
| Bone-conduction Hearing Device | Hearing Performance: Threshold Audiometry, Pure Tone Average, PTA4, Unaided Versus OSIA System at 4 Weeks, 6 and 12 Months | 12 months | -30.4 dB | Standard Deviation 8.9 |
Comparison: PTA4 at 4 weeks with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: PTA4 at 6 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: PTA4 at 12 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Secondary
Incision Type
Surgical information: a question was asked regarding what type of incision had been used; C-shaped flap, posterior based flap or other could be ticked.
Time frame: Visit 2, surgery
Population: For two subjects two alternatives were checked.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bone-conduction Hearing Device | Incision Type | Other | 22 Participants |
| Bone-conduction Hearing Device | Incision Type | C-shaped flap | 30 Participants |
| Bone-conduction Hearing Device | Incision Type | Poesterior flap | 1 Participants |
Secondary
Location of BI300 Implant
Surgical information: where is the location of the BI300 implant, measured in two different ways: Alternative 1 used for the first 6 subjects: Location from the ear channel in mm. Alternative 2 used for the rest of the population 45 subjects, after an amendment: measured in mm horizontally and vertically from ear channel. and the distance in mm between the receiver and the coil. Value 9.64 mm vertically from ear channel is correct.
Time frame: Visit 2, surgery
Population: Localization of the BI300 implant measured in two different ways; 6 subjects with alternative 1, 45 subjects with alternative 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bone-conduction Hearing Device | Location of BI300 Implant | Alt 1: distance from the ear channel | 48.3 mm | Standard Deviation 10.3 |
| Bone-conduction Hearing Device | Location of BI300 Implant | 9.64Alt 2: horizontally from ear channel | 40.0 mm | Standard Deviation 17.9 |
| Bone-conduction Hearing Device | Location of BI300 Implant | Alt 2: vertically from the ear channel | 9.64 mm | Standard Deviation 9.2 |
| Bone-conduction Hearing Device | Location of BI300 Implant | Alt 2: distance between receiver and coil | 54.4 mm | Standard Deviation 13.8 |
Secondary
Magnet Choice
Available magnet strengths: 1/2, 1, 2, 3, 4, 5 or 6, where 1/2 is the weakest and 6 the strongest.
Time frame: 4, 6 weeks, 3, 6 and 12 months
Population: Some of the subjects did not perform all visits.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bone-conduction Hearing Device | Magnet Choice | 12 months strength 2 | 12 Participants |
| Bone-conduction Hearing Device | Magnet Choice | 4 weeks: strength 1/2 | 0 Participants |
| Bone-conduction Hearing Device | Magnet Choice | 4 weeks: strength 1 | 1 Participants |
| Bone-conduction Hearing Device | Magnet Choice | 4 weeks: strength 2 | 11 Participants |
| Bone-conduction Hearing Device | Magnet Choice | 4 weeks: strength 3 | 13 Participants |
| Bone-conduction Hearing Device | Magnet Choice | 4 weeks: strength 4 | 12 Participants |
| Bone-conduction Hearing Device | Magnet Choice | 4 weeks: strength 5 | 8 Participants |
| Bone-conduction Hearing Device | Magnet Choice | 4 weeks: strength 6 | 5 Participants |
| Bone-conduction Hearing Device | Magnet Choice | 6 weeks strength 1/2 | 0 Participants |
| Bone-conduction Hearing Device | Magnet Choice | 6 weeks strength 1 | 1 Participants |
| Bone-conduction Hearing Device | Magnet Choice | 6 weeks strength 2 | 10 Participants |
| Bone-conduction Hearing Device | Magnet Choice | 6 weeks strength 3 | 11 Participants |
| Bone-conduction Hearing Device | Magnet Choice | 6 weeks strength 4 | 13 Participants |
| Bone-conduction Hearing Device | Magnet Choice | 6 weeks strength 5 | 9 Participants |
| Bone-conduction Hearing Device | Magnet Choice | 6 weeks strength 6 | 5 Participants |
| Bone-conduction Hearing Device | Magnet Choice | 3 months strength 1/2 | 0 Participants |
| Bone-conduction Hearing Device | Magnet Choice | 3 months strength 1 | 1 Participants |
| Bone-conduction Hearing Device | Magnet Choice | 3 months strength 2 | 12 Participants |
| Bone-conduction Hearing Device | Magnet Choice | 3 months strength 3 | 10 Participants |
| Bone-conduction Hearing Device | Magnet Choice | 3 months strength 4 | 14 Participants |
| Bone-conduction Hearing Device | Magnet Choice | 3 months strength 5 | 8 Participants |
| Bone-conduction Hearing Device | Magnet Choice | 3 months strength 6 | 5 Participants |
| Bone-conduction Hearing Device | Magnet Choice | 6 months strength 1/2 | 0 Participants |
| Bone-conduction Hearing Device | Magnet Choice | 6 months strength 1 | 2 Participants |
| Bone-conduction Hearing Device | Magnet Choice | 6 months strength 2 | 11 Participants |
| Bone-conduction Hearing Device | Magnet Choice | 6 months strength 3 | 11 Participants |
| Bone-conduction Hearing Device | Magnet Choice | 6 months strength 4 | 13 Participants |
| Bone-conduction Hearing Device | Magnet Choice | 6 months strength 5 | 10 Participants |
| Bone-conduction Hearing Device | Magnet Choice | 6 months strength 6 | 3 Participants |
| Bone-conduction Hearing Device | Magnet Choice | 12 months strength 1/2 | 0 Participants |
| Bone-conduction Hearing Device | Magnet Choice | 12 months strength 1 | 2 Participants |
| Bone-conduction Hearing Device | Magnet Choice | 12 months strength 3 | 10 Participants |
| Bone-conduction Hearing Device | Magnet Choice | 12 months strength 4 | 11 Participants |
| Bone-conduction Hearing Device | Magnet Choice | 12 months strength 5 | 10 Participants |
| Bone-conduction Hearing Device | Magnet Choice | 12 months strength 6 | 3 Participants |
Secondary
Softpad Use
A question was asked if the subjects used softpads; yes or no could be ticked.
Time frame: 6 weeks, 3, 6 and 12 months
Population: Some of the subjects did not answer the question at all visits.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bone-conduction Hearing Device | Softpad Use | 6 weeks: yes | 1 Participants |
| Bone-conduction Hearing Device | Softpad Use | 6 weeks: no | 47 Participants |
| Bone-conduction Hearing Device | Softpad Use | 3 months: yes | 4 Participants |
| Bone-conduction Hearing Device | Softpad Use | 3 months: no | 45 Participants |
| Bone-conduction Hearing Device | Softpad Use | 6 months: yes | 0 Participants |
| Bone-conduction Hearing Device | Softpad Use | 6 months: no | 50 Participants |
| Bone-conduction Hearing Device | Softpad Use | 12 months: yes | 3 Participants |
| Bone-conduction Hearing Device | Softpad Use | 12 months: no | 44 Participants |
Secondary
Soft Tissue Reduction
Surgical information: a question was asked if soft tissue reduction had been performed. Could be answered by ticking a box for Yes or No.
Time frame: Visit 2, surgery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bone-conduction Hearing Device | Soft Tissue Reduction | Yes | 10 Participants |
| Bone-conduction Hearing Device | Soft Tissue Reduction | No | 41 Participants |
Secondary
Soft Tissue Thickness
Surgical information: Soft tissue thickness was measured in mm
Time frame: Visit 2, surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone-conduction Hearing Device | Soft Tissue Thickness | 6.00 mm | Standard Deviation 1.3 |
Secondary
Speech in Quiet at 50, 65 and 80 dB SPL, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months
The change of hearing performance from the unaided hearing situation before surgery to the aided hearing situation with the OSIA System at 4 weeks, 3, 6 and 12 months, measured as free-field hearing test Speech in quiet at 50, 65 and 80 dB SPL \[% correctly perceived words at 50, 65 and 80 dB SPL\] is presented. The change in percent points is presented. A positive value indicates an improved ability to perceive words in quiet at the specified decibel (dB) level a negative value represent an impairment.
Time frame: Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.
Population: Some of the subjects did not perform the test at one or more visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bone-conduction Hearing Device | Speech in Quiet at 50, 65 and 80 dB SPL, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 6 months: 50 dB | 46.5 Percentage of correctly perceived words | Standard Deviation 29.5 |
| Bone-conduction Hearing Device | Speech in Quiet at 50, 65 and 80 dB SPL, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 6 months: 65 dB | 61.5 Percentage of correctly perceived words | Standard Deviation 27.7 |
| Bone-conduction Hearing Device | Speech in Quiet at 50, 65 and 80 dB SPL, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 6 months: 80 dB | 30.7 Percentage of correctly perceived words | Standard Deviation 33.3 |
| Bone-conduction Hearing Device | Speech in Quiet at 50, 65 and 80 dB SPL, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 12 months: 50 dB | 57.8 Percentage of correctly perceived words | Standard Deviation 24.9 |
| Bone-conduction Hearing Device | Speech in Quiet at 50, 65 and 80 dB SPL, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 12 months: 65 dB | 68.3 Percentage of correctly perceived words | Standard Deviation 23.6 |
| Bone-conduction Hearing Device | Speech in Quiet at 50, 65 and 80 dB SPL, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 12 months: 80 dB | 32.7 Percentage of correctly perceived words | Standard Deviation 32.4 |
| Bone-conduction Hearing Device | Speech in Quiet at 50, 65 and 80 dB SPL, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 4 weeks; 50 dB | 38.0 Percentage of correctly perceived words | Standard Deviation 27 |
| Bone-conduction Hearing Device | Speech in Quiet at 50, 65 and 80 dB SPL, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 4 weeks; 65 dB | 59.8 Percentage of correctly perceived words | Standard Deviation 28.8 |
| Bone-conduction Hearing Device | Speech in Quiet at 50, 65 and 80 dB SPL, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 4 weeks; 80 dB | 29.3 Percentage of correctly perceived words | Standard Deviation 30.8 |
| Bone-conduction Hearing Device | Speech in Quiet at 50, 65 and 80 dB SPL, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 3 months: 50 dB | 40.1 Percentage of correctly perceived words | Standard Deviation 26.8 |
| Bone-conduction Hearing Device | Speech in Quiet at 50, 65 and 80 dB SPL, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 3 months: 65 dB | 60.6 Percentage of correctly perceived words | Standard Deviation 26.8 |
| Bone-conduction Hearing Device | Speech in Quiet at 50, 65 and 80 dB SPL, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months | 3 months: 80 dB | 31.8 Percentage of correctly perceived words | Standard Deviation 31.9 |
Comparison: Speech in quiet at 50dB at 4 weeks with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Speech in quiet at 65dB at 4 weeks with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Speech in quiet at 80dB at 4 weeks with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Speech in quiet at 50dB at 3 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Speech in quiet at 65dB at 3 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Speech in quiet at 80dB at 3 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Speech in quiet at 50dB at 6 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Speech in quiet at 65dB at 6 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Speech in quiet at 80dB at 6 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Speech in quiet at 50dB at 12 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Speech in quiet at 65dB at 12 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Wilcoxon (Mann-Whitney)
Comparison: Speech in quiet at 80dB at 12 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Secondary
Speech in Quiet at 50, 65 and 80 dB SPL, With Reference Device BP110
The change of hearing performance with the OSIA System at 4 weeks, 3, 6 and 12 months compared to the pre-operative aided situation with BP110 on softband measured as free-field hearing test; Speech in quiet \[% correctly perceived words at 50, 65 and 80 dB SPL\]. The change in percent points is presented. A positive value indicates an improved ability to perceive words in quiet at the specified decibel (dB) level a negative value represent an impairment.
Time frame: Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.
Population: Some of the subjects did not perform all measurements at all visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bone-conduction Hearing Device | Speech in Quiet at 50, 65 and 80 dB SPL, With Reference Device BP110 | 3 months: 50 dB SPL | 5.17 Percentage of correctly perceived words | Standard Deviation 26.16 |
| Bone-conduction Hearing Device | Speech in Quiet at 50, 65 and 80 dB SPL, With Reference Device BP110 | 3 months: 65 dB SPL | 7.48 Percentage of correctly perceived words | Standard Deviation 21.39 |
| Bone-conduction Hearing Device | Speech in Quiet at 50, 65 and 80 dB SPL, With Reference Device BP110 | 4 weeks: 50 dB SPL | 2.40 Percentage of correctly perceived words | Standard Deviation 24.81 |
| Bone-conduction Hearing Device | Speech in Quiet at 50, 65 and 80 dB SPL, With Reference Device BP110 | 4 weeks: 65 dB SPL | 6.65 Percentage of correctly perceived words | Standard Deviation 19.58 |
| Bone-conduction Hearing Device | Speech in Quiet at 50, 65 and 80 dB SPL, With Reference Device BP110 | 4 weeks: 80 dB SPL | 1.17 Percentage of correctly perceived words | Standard Deviation 7.34 |
| Bone-conduction Hearing Device | Speech in Quiet at 50, 65 and 80 dB SPL, With Reference Device BP110 | 3 months: 80 dB SPL | 1.77 Percentage of correctly perceived words | Standard Deviation 8.35 |
| Bone-conduction Hearing Device | Speech in Quiet at 50, 65 and 80 dB SPL, With Reference Device BP110 | 6 months: 50 dB SPL | 10.3 Percentage of correctly perceived words | Standard Deviation 24.4 |
| Bone-conduction Hearing Device | Speech in Quiet at 50, 65 and 80 dB SPL, With Reference Device BP110 | 6 months: 65 dB SPL | 7.73 Percentage of correctly perceived words | Standard Deviation 22.56 |
| Bone-conduction Hearing Device | Speech in Quiet at 50, 65 and 80 dB SPL, With Reference Device BP110 | 6 months: 80 dB SPL | 0.875 Percentage of correctly perceived words | Standard Deviation 10.02 |
| Bone-conduction Hearing Device | Speech in Quiet at 50, 65 and 80 dB SPL, With Reference Device BP110 | 12 months: 50 dB SPL | 20.7 Percentage of correctly perceived words | Standard Deviation 29.5 |
| Bone-conduction Hearing Device | Speech in Quiet at 50, 65 and 80 dB SPL, With Reference Device BP110 | 12 months: 65 dB SPL | 13.9 Percentage of correctly perceived words | Standard Deviation 22.3 |
| Bone-conduction Hearing Device | Speech in Quiet at 50, 65 and 80 dB SPL, With Reference Device BP110 | 12 months: 80 dB SPL | 3.61 Percentage of correctly perceived words | Standard Deviation 10.45 |
Comparison: Speech in quiet at 50dB SPL with Osia at 4 weeks vs reference device BP110 on softband att visit 1.p-value: 0.51Fisher's non-parametric permutation test
Comparison: Speech in quiet at 65dB SPL with Osia at 4 weeks vs reference device BP110 on softband att visit 1.p-value: 0.021Fisher's non-parametric permutation test
Comparison: Speech in quiet at 80dB SPL with Osia at 4 weeks vs reference device BP110 on softband att visit 1.p-value: 0.29Fisher's non-parametric permutation test
Comparison: Speech in quiet at 50dB SPL with Osia at 3 months vs reference device BP110 on softband att visit 1.p-value: 0.18Fisher's non-parametric permutation test
Comparison: Speech in quiet at 65dB SPL with Osia at 3 months vs reference device BP110 on softband att visit 1.p-value: 0.017Fisher's non-parametric permutation test
Comparison: Speech in quiet at 80dB SPL with Osia at 3 months vs reference device BP110 on softband att visit 1.p-value: 0.16Fisher's non-parametric permutation test
Comparison: Speech in quiet at 50dB SPL with Osia at 6 months vs reference device BP110 on softband att visit 1.p-value: 0.0051Fisher's non-parametric permutation test
Comparison: Speech in quiet at 65dB SPL with Osia at 6 months vs reference device BP110 on softband att visit 1.p-value: 0.021Fisher's non-parametric permutation test
Comparison: Speech in quiet at 80dB SPL with Osia at 6 months vs reference device BP110 on softband att visit 1.p-value: 0.56Fisher's non-parametric permutation test
Comparison: Speech in quiet at 50dB SPL with Osia at 12 months vs reference device BP110 on softband att visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Speech in quiet at 65dB SPL with Osia at 12 months vs reference device BP110 on softband att visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: Speech in quiet at 80dB SPL with Osia at 12 months vs reference device BP110 on softband att visit 1.p-value: 0.041Wilcoxon Signed Rank test
Secondary
Speech, Spatial and Qualities of Hearing Scale (SSQ) at 3 and 12 Months
The change of speech, spatial and hearing experiences from the unaided hearing situation before surgery to the aided hearing situation with the OSIA System at 3 and 12 months using the SSQ scale is presented. All subscales (speech, spatial, quality) range from 0 to 10, where 0 represents can not hear at all, and 10 hear perfectly. Total score is a average of the subscales. A positive value indicates improved hearing, a negative value indicates impaired hearing.
Time frame: Baseline before surgery and 3 and 12 months after surgery
Population: Some of the subjects did not answer all questions at one or both visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bone-conduction Hearing Device | Speech, Spatial and Qualities of Hearing Scale (SSQ) at 3 and 12 Months | 3 months: Total score | 2.57 units on a scale | Standard Deviation 2.01 |
| Bone-conduction Hearing Device | Speech, Spatial and Qualities of Hearing Scale (SSQ) at 3 and 12 Months | 3 months: Speech score | 2.91 units on a scale | Standard Deviation 2.19 |
| Bone-conduction Hearing Device | Speech, Spatial and Qualities of Hearing Scale (SSQ) at 3 and 12 Months | 3 months: Spatial score | 2.85 units on a scale | Standard Deviation 2.5 |
| Bone-conduction Hearing Device | Speech, Spatial and Qualities of Hearing Scale (SSQ) at 3 and 12 Months | 3 months: Quality score | 1.88 units on a scale | Standard Deviation 2.38 |
| Bone-conduction Hearing Device | Speech, Spatial and Qualities of Hearing Scale (SSQ) at 3 and 12 Months | 12 months: Total score | 2.69 units on a scale | Standard Deviation 1.75 |
| Bone-conduction Hearing Device | Speech, Spatial and Qualities of Hearing Scale (SSQ) at 3 and 12 Months | 12 months: Speech score | 2.94 units on a scale | Standard Deviation 1.94 |
| Bone-conduction Hearing Device | Speech, Spatial and Qualities of Hearing Scale (SSQ) at 3 and 12 Months | 12 months: Spatial score | 2.95 units on a scale | Standard Deviation 2.52 |
| Bone-conduction Hearing Device | Speech, Spatial and Qualities of Hearing Scale (SSQ) at 3 and 12 Months | 12 months: Quality score | 2.13 units on a scale | Standard Deviation 2.3 |
Comparison: SSQ Total score at 3 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: SSQ Speech score at 3 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: SSQ Spatial score at 3 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: SSQ Quality score at 3 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: SSQ Total score at 12 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: SSQ Speech score at 12 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: SSQ Spatial score at 12 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Comparison: SSQ Quality score at 12 months with the Osia system vs Unaided at visit 1.p-value: <0.0001Fisher's non-parametric permutation test
Secondary
Surgical Information: Time of Surgery
Surgery time in minutes between first incision and last suture
Time frame: Visit 2, surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone-conduction Hearing Device | Surgical Information: Time of Surgery | 97.2 minutes | Standard Deviation 27.8 |
Secondary
Type of Anaesthesia
Surgical information: a question is asked which type of anaesthesia has been used: local or general can be ticked.
Time frame: Visit 2, surgery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bone-conduction Hearing Device | Type of Anaesthesia | General | 51 Participants |
| Bone-conduction Hearing Device | Type of Anaesthesia | Local | 0 Participants |