Deafness, Hearing Loss, Hearing Loss, Conductive
Conditions
Brief summary
The rationale behind this post-market clinical follow-up investigation is to collect data regarding the usability and clinical performance of the Baha Attract System in subjects with hearing impairment that are candidates for Baha surgery: * to evaluate the efficacy of the Baha Attract System in terms of hearing performance compared to the unaided situation and compared to a pre-operative test situation using the sound processor on a Baha Softband; * to evaluate the mid- and long-term safety of the Baha Attract System.
Detailed description
This investigation was designed to collect data regarding the usability and clinical performance of the Baha Attract System in subjects with hearing impairment that were candidates for Baha surgery. The investigation was performed in an open design since it was not possible to perform the investigation in a blinded fashion. The main evaluations of the investigation, i.e. free-field hearing tests, are standard audiological procedures that are routinely used in daily clinical practice at hospitals worldwide for evaluation of hearing performance in hearing impaired patients. The primary efficacy evaluation, audiometric thresholds, renders comparable results across different sites and countries as it is not a language-specific test. Language-specific audiological tests were performed as secondary efficacy evaluations; to enable comparison of data across sites, validated word lists were used at all sites and equivalent speaker configurations (speech from front, noise from behind) and test procedures (same noise and adaptive speech levels, etc) were used. For the primary evaluation in the investigation, the Baha Attract System was compared to the pre-operative unaided situation, as the intended use of the system is to improve hearing performance in patients with conductive or mixed hearing loss or single-sided sensorineural deafness. Audiological test results with the Baha Attract System were also compared against results obtained with the same Sound Processor on a Baha Softband. Use of the Sound Processor on a Softband is a standard procedure that is routinely used as a pre-operative test prior to bone conduction hearing implant surgery. The Softband test allows the patient to pre-operatively experience hearing through the Sound Processor to get an indication of the post-operative hearing outcome and to choose a suitable Sound Processor. The generic and hearing-specific quality of life questionnaires used in the investigation (HUI3, APHAB, SSQ) are validated scales that have been frequently used and reported in the literature.
Interventions
DEVICEBaha Attract System
The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
Sponsors
Cochlear Bone Anchored Solutions
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
No
Inclusion criteria
Adult subject, i.e. ≥ 18 years of age Conductive or mixed hearing loss in the ear to be implanted: Bone conduction thresholds with a pure tone average PTA4 of \< 30 dB hearing level (mean of 500, 1000, 2000 and 4000 Hz). OR Single-sided sensorineural deafness (SSD): European sites: Bone conduction thresholds with a pure tone average PTA4 of \< 30dB hearing level (mean of 500, 1000, 2000 and 4000 Hz) in the good ear. US sites: Air conduction thresholds with a pure tone average PTA4 of 20 dB hearing level (mean of 500, 1000, 2000 and 3000 Hz) in the good ear OR Subject is indicated for an AC CROS but-for some reason-cannot or will not use an AC CROS. No previous bone conduction implant on the side of the skull to be implanted. Signed informed consent.
Exclusion criteria
Subjects that are scheduled for simultaneous bilateral implant surgery. The investigation is limited to subjects with unilateral use of the Baha Attract System (however, bilateral hearing loss is not an exclusion criterion). Suitable implant position for the BI300 Implant (4 mm or 3 mm) not found during surgery due to insufficient bone quality and/or bone thickness. Less than 3 mm soft tissue thickness at the planned implant site. Subjects that have received radiation therapy at the same side of the skull where the Baha Attract System will be positioned. Condition that could jeopardise osseointegration and/or wound healing as judged by the investigator (e.g. osteoporosis, psoriasis, use of corticosteroids). Uncontrolled diabetes as judged by the investigator. Condition that may have an impact on the outcome of the investigation as judged by the investigator. Unable to follow investigational procedures (e.g. to complete quality of life scales). Participation in another investigation with pharmaceuticals and/or medical device.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hearing Performance: Threshold Audiometry PTA4: Unaided Versus Baha Attract | Baseline (unaided) before surgery, 6, 12 and 24 months after surgery | The change of hearing performance with the Baha Attract System (aided) at 6, 12 and 24 months from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz). The units reported for PTA4 are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds. |
| Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract | Baseline (unaided) before surgery, 24 months after surgery | The change of hearing performance with the Baha Attract System (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz). The units reported for PTA4 are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hearing Performance: Threshold Audiometry PTA4: Sound Processor on Softband Versus Baha Attract | Baseline before surgery, 6, 12 and 24 months after surgery | The change of hearing performance with the Baha Attract System (aided) from the aided hearing performance, sound processor on a softband, before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz) The units reported for PTA4 are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds. |
| Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband | Baseline (aided) before surgery, 6 months after surgery | The change of hearing performance with the Baha Attract System (aided) from the aided hearing performance with Sound processor on a Softband before surgery; measured as free-field hearing tests: Threshold audiometry at individual frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 Hz. The units reported for threshold audiometry are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds. |
| Adaptive Speech Recognition in Noise Ratio: Baha Attract Versus Sound Processor on Softband | Baseline (aided) before surgery, 6, 12 and 24 months after surgery | The change of hearing performance with the Baha Attract System compared to the pre-operative aided situation with Sound Processor on a softband; Adaptive Speech recognition in Noise measured as signal to noise ratio. A ratio of 1 reflects the ability to correctly hear sentences at 65 dB, in the presence of 65 dB background noise. A lower ratio than 1 reflects the ability to correctly hear sentences below 65 dB. A ratio higher than 1 reflects the ability to correctly hear sentences presented above 65 dB. |
| Speech in Quiet: Baha Attract Versus Sound Processor on Softband | Baseline (aided) before surgery, 6, 12 and 24 months after surgery | The change of hearing performance with the Baha Attract System at 6 months compared to the pre-operative aided situation with the Sound Processor on a softband; Speech in quiet at 50, 65 and 80dB. Speech in Quiet is a measure of percentage of correct words. A higher score reflects a higher percentage of correct words. |
| Health Utility Index (HUI) | Baseline (unaided) before surgery, 6 and 24 months after surgery | Change of health status and health related quality of life using the generic quality of life scale Health Utilities Index (HUI3) when wearing Baha Attract System compared to the pre-operative unaided situation. A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The change from unaided to aided hearing is presented. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life. HUI score of 1 (maximum) describes a state of perfect health. HUI score of 0 describes a state of dead. A negative score of Comprehensive Health State describes a state worse than dead. |
| Abbreviated Profile of Hearing Aid Benefit (APHAB) | Baseline before surgery, 6 and 24 months after surgery | Measuring change of Ease of communication, Reverberation, Background noise, Aversiveness and a Global score with the Baha Attract System from the pre-operative unaided situation. The absolute APHAB scale is between 0 and 100%, where 0% indicates no problems and 100% indicates always problem. The change from unaided to aided hearing is presented. A positive value indicates an improvement, a negative value an impairment. |
| Speech, Spatial and Qualities of Hearing Scale (SSQ) | Baseline before surgery, 6 and 24 months after surgery | Measuring change of speech, spatial and hearing experiences with the Baha Attract System from the pre-operative unaided situation. A scale from 0 to 10, where 0 represents can not hear at all, and 10 hear perfectly. The change from unaided to aided hearing is presented. A positive value indicates improved hearing, a negative value indicates impaired hearing. |
| Adaptive Speech Recognition in Noise Ratio: Unaided Versus Baha Attract | Baseline (unaided) before surgery, 6, 12 and 24 months after surgery | The change of hearing performance with the Baha Attract System compared to the pre-operative unaided situation; Adaptive speech recognition in noise measured as signal to noise ratio The adaptive speech test in noise was conducted using validated lists of phonetically balanced sentences, with speech presented from the front (0 degrees azimuth) and noise from the back (180 degrees azimuth). The noise was kept constant at 65 dB SPL, and the speech was adapted in 2 dB steps to establish the speech-to-noise ratio (SNR) providing a 50% level of understanding. A ratio of 1 reflects the ability to correctly hear sentences at 65 dB, in the presence of 65 dB background noise. A lower ratio than 1 reflects the ability to correctly hear sentences below 65 dB. A ratio higher than 1 reflects the ability to correctly hear sentences presented above 65 dB. Manchester and Birmingham are excluded from this analysis due to incorrect set up. |
| Tissue Reduction Performed During Surgery | Visit 2 (surgery) | Surgical thinning of the soft tissue flap was advocated when the soft tissue thickness exceeded 6 mm |
| Implant Stability | Visit 2 (surgery) | Implant Stability Quotient - ISQ, a scale from 1 to 100, where 100 represent the highest stability |
| Magnetic Force | 4, 6, 12 weeks, 6, 12 and 24 months | To investigate if the magnetic force required for sound processor magnet retention will change over time |
| Sound Processor Magnet Choice | 4, 6, 12 weeks, 6, 12 and 24 months | To investigate how sound processor magnet choice will change over time. Six different magnetic strength could be chosen; SPM 1 had the lowest strength and SPM 6 the the highest. |
| Pain & Discomfort | Week 6, Week 12, Month 6, Month 12, Month 24 | Degree of pain and discomfort. |
| Numbness When Tested With a Pin | Day 10, Week 4, Week 6, Week 12, Month 6, Month 12, Month 24 | Degree of numbness when tested with a pin |
| Numbness When Tested With a Cotton Swab | Day 10, Week 4, Week 6, Week 12, Month 6, Month 12, Month 24 | Degree of numbness when tested with a Cotton Swab |
| Time to Perform Surgery | Visit 2 (Surgery) | Time of first incision to time of last suture |
| Speech in Quiet, Baha Attract Versus Unaided | Baseline before surgery, 6, 12 and 24 months after surgery | The change of hearing performance with the Baha Attract System at 6, 12 and 24 months compared to the pre-operative unaided situation; Speech in quiet at 50, 65 and 80dB. Speech in Quiet is a measure of percentage of correct words. A higher score reflects a higher percentage of correct words. |
Countries
Netherlands, Poland, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Baha Attract System This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;
* One implant magnet
* One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)
Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling. | 54 |
| Total | 54 |
Baseline characteristics
| Characteristic | Baha Attract System |
|---|---|
| Age, Continuous | 42.1 years STANDARD_DEVIATION 13.6 |
| Region of Enrollment Netherlands | 23 participants |
| Region of Enrollment Poland | 14 participants |
| Region of Enrollment United Kingdom | 16 participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 21 Participants |
| Type of hearing loss Conductive hearing loss | 39 participants |
| Type of hearing loss Single-sided sensorineural deafness | 15 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 54 |
| other Total, other adverse events | 29 / 54 |
| serious Total, serious adverse events | 13 / 54 |
Outcome results
Primary
Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract
The change of hearing performance with the Baha Attract System (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry at frequencies of 250, 500, 1000, 2000, 3000, 4000 and 6000 Hz). The units reported for threshold audiometry are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Time frame: Baseline (unaided) before surgery, 12 months after surgery
Population: Intention-to-Treat population (ITT); includes all subjects who received the surgical intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baha Attract System | Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract | Change of Threshold value at 250 Hz | -18.5 dB | Standard Deviation 14.3 |
| Baha Attract System | Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract | Change of Threshold value at 500 Hz | -26.0 dB | Standard Deviation 13 |
| Baha Attract System | Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract | Change of Threshold value at 1000 Hz | -26.5 dB | Standard Deviation 14.2 |
| Baha Attract System | Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract | Change of Threshold value at 4000 Hz | -12.5 dB | Standard Deviation 12.2 |
| Baha Attract System | Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract | Change of Threshold value at 2000 Hz | -18.5 dB | Standard Deviation 13.5 |
| Baha Attract System | Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract | Change of Threshold value at 3000 Hz | -16.3 dB | Standard Deviation 13.2 |
| Baha Attract System | Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract | Change of Threshold value at 6000 Hz | -7.25 dB | Standard Deviation 11.19 |
Comparison: Baha Attract after 12 months vs Unaided situation Pre-Opp-value: <0.0001Fisher's non-parametric permutation test
Primary
Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract
The change of hearing performance with the Baha Attract System (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz). The units reported for PTA4 are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Time frame: Baseline (unaided) before surgery, 24 months after surgery
Population: Intention-to-Treat population (ITT); includes all subjects who received the surgical intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baha Attract System | Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract | Change of Threshold value at 250 Hz | -19.9 dB | Standard Deviation 11 |
| Baha Attract System | Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract | Change of Threshold value at 2000 Hz | -19.6 dB | Standard Deviation 11.8 |
| Baha Attract System | Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract | Change of Threshold value at 3000 Hz | -18.4 dB | Standard Deviation 10.9 |
| Baha Attract System | Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract | Change of Threshold value at 500 Hz | -25.3 dB | Standard Deviation 9.6 |
| Baha Attract System | Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract | Change of Threshold value at 1000 Hz | -28.0 dB | Standard Deviation 12.4 |
| Baha Attract System | Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract | Change of Threshold value at 4000 Hz | 13.2 dB | Standard Deviation 12 |
| Baha Attract System | Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract | Change of Threshold value at 6000 Hz | -8.67 dB | Standard Deviation 8.88 |
Comparison: Baha Attract after 24 months vs Unaided situation Pre-Opp-value: <0.0001Fisher's non-parametric permutation test
Primary
Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract
The change of hearing performance with the Baha Attract System (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry at individual frequencies 250, 500, 1000, 2000, 3000, 4000 and 6000 Hz. The units reported for threshold audiometry are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Time frame: Baseline (unaided) before surgery, 6 months after surgery
Population: Intention-to-Treat population (ITT); includes all subjects who received the surgical intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baha Attract System | Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract | Change of Threshold value at 500 Hz | -26.6 dB | Standard Deviation 12.8 |
| Baha Attract System | Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract | Change of Threshold value at 6000 Hz | -7.04 dB | Standard Deviation 8.61 |
| Baha Attract System | Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract | Change of Threshold value at 250 Hz | -16.9 dB | Standard Deviation 12.9 |
| Baha Attract System | Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract | Change of Threshold value at 1000 Hz | -26.4 dB | Standard Deviation 14.1 |
| Baha Attract System | Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract | Change of Threshold value at 2000 Hz | -18.7 dB | Standard Deviation 12.1 |
| Baha Attract System | Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract | Change of Threshold value at 3000 Hz | -16.9 dB | Standard Deviation 12.7 |
| Baha Attract System | Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract | Change of Threshold value at 4000 Hz | -12.3 dB | Standard Deviation 10.6 |
Comparison: Baha Attract after 6 months vs Unaided situation Pre-Opp-value: <0.0001Fisher's non-parametric permutation test
Primary
Hearing Performance: Threshold Audiometry PTA4: Unaided Versus Baha Attract
The change of hearing performance with the Baha Attract System (aided) at 6, 12 and 24 months from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz). The units reported for PTA4 are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Time frame: Baseline (unaided) before surgery, 6, 12 and 24 months after surgery
Population: Intention-to-Treat (ITT) population; includes all subjects who received the surgical intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baha Attract System | Hearing Performance: Threshold Audiometry PTA4: Unaided Versus Baha Attract | PTA4 6 months, Baha Attract vs Unaided | -21.0 dB | Standard Deviation 10.4 |
| Baha Attract System | Hearing Performance: Threshold Audiometry PTA4: Unaided Versus Baha Attract | PTA4 24 months, Baha Attract vs Unaided | -21.5 dB | Standard Deviation 8.3 |
| Baha Attract System | Hearing Performance: Threshold Audiometry PTA4: Unaided Versus Baha Attract | PTA4 12 months, Baha Attract vs Baha Attract | -20.9 dB | Standard Deviation 10.4 |
Comparison: PTA4 6 months with Baha Attract vs Unaidedp-value: <0.0001Fisher's non-parametric permutation test
Comparison: PTA4 12 months with Baha Attract vs Unaidedp-value: <0.0001Fisher's non-parametric permutation test
Comparison: PTA4 24 months with Baha Attract vs Unaidedp-value: <0.0001Fisher's non-parametric permutation test
Secondary
Abbreviated Profile of Hearing Aid Benefit (APHAB)
Measuring change of Ease of communication, Reverberation, Background noise, Aversiveness and a Global score with the Baha Attract System from the pre-operative unaided situation. The absolute APHAB scale is between 0 and 100%, where 0% indicates no problems and 100% indicates always problem. The change from unaided to aided hearing is presented. A positive value indicates an improvement, a negative value an impairment.
Time frame: Baseline before surgery, 6 and 24 months after surgery
Population: Intention-to-Treat (ITT) population; includes all patients who received the surgical intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baha Attract System | Abbreviated Profile of Hearing Aid Benefit (APHAB) | 6 months: Background noise | 26.3 units on scale | Standard Deviation 20.6 |
| Baha Attract System | Abbreviated Profile of Hearing Aid Benefit (APHAB) | 6 months: Reverberation | 22.0 units on scale | Standard Deviation 19 |
| Baha Attract System | Abbreviated Profile of Hearing Aid Benefit (APHAB) | 24 months: Reverberation | 20.8 units on scale | Standard Deviation 19.9 |
| Baha Attract System | Abbreviated Profile of Hearing Aid Benefit (APHAB) | 6 months: Ease of communication | 20.4 units on scale | Standard Deviation 24.9 |
| Baha Attract System | Abbreviated Profile of Hearing Aid Benefit (APHAB) | 6 months: Aversiveness | 1.32 units on scale | Standard Deviation 23.45 |
| Baha Attract System | Abbreviated Profile of Hearing Aid Benefit (APHAB) | 6 months: Global | 22.9 units on scale | Standard Deviation 18.1 |
| Baha Attract System | Abbreviated Profile of Hearing Aid Benefit (APHAB) | 24 months: Ease of communication | 18.7 units on scale | Standard Deviation 26.3 |
| Baha Attract System | Abbreviated Profile of Hearing Aid Benefit (APHAB) | 24 months: Background noise | 23.7 units on scale | Standard Deviation 20.4 |
| Baha Attract System | Abbreviated Profile of Hearing Aid Benefit (APHAB) | 24 months: Aversiveness | -0.596 units on scale | Standard Deviation 19.646 |
| Baha Attract System | Abbreviated Profile of Hearing Aid Benefit (APHAB) | 24 months: Global | 21.1 units on scale | Standard Deviation 18.9 |
Comparison: 6 months: Ease of communicationp-value: <0.0001Fisher's non-parametric permutation test
Comparison: 6 months: Background noisep-value: <0.0001Fisher's non-parametric permutation test
Comparison: 6 months: Reverberationp-value: <0.0001Fisher's non-parametric permutation test
Comparison: 6 months: Aversivenessp-value: 0.69Fisher's non-parametric permutation test
Comparison: 6 months: Globalp-value: <0.0001Fisher's non-parametric permutation test
Comparison: 24 months: Ease of communicationp-value: <0.001Fisher's non-parametric permutation test
Comparison: 24 months: Background noisep-value: <0.001Fisher's non-parametric permutation test
Comparison: 24 months: Reverberationp-value: <0.001Fisher's non-parametric permutation test
Comparison: 24 months: Aversivenessp-value: 0.84Fisher's non-parametric permutation test
Comparison: 24 months: Globalp-value: <0.001Fisher's non-parametric permutation test
Secondary
Adaptive Speech Recognition in Noise Ratio: Baha Attract Versus Sound Processor on Softband
The change of hearing performance with the Baha Attract System compared to the pre-operative aided situation with Sound Processor on a softband; Adaptive Speech recognition in Noise measured as signal to noise ratio. A ratio of 1 reflects the ability to correctly hear sentences at 65 dB, in the presence of 65 dB background noise. A lower ratio than 1 reflects the ability to correctly hear sentences below 65 dB. A ratio higher than 1 reflects the ability to correctly hear sentences presented above 65 dB.
Time frame: Baseline (aided) before surgery, 6, 12 and 24 months after surgery
Population: Intention-to-Treat (ITT) population; includes all patient who received the surgical intervention.~Speech in Noise analysis excludes patients from Birmingham and Manchester due to incorrect set up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baha Attract System | Adaptive Speech Recognition in Noise Ratio: Baha Attract Versus Sound Processor on Softband | 6 months: Speech in Noise | -0.508 change in SNR dB | Standard Deviation 4.173 |
| Baha Attract System | Adaptive Speech Recognition in Noise Ratio: Baha Attract Versus Sound Processor on Softband | 12 months: Speech in Noise | -1.05 change in SNR dB | Standard Deviation 4.75 |
| Baha Attract System | Adaptive Speech Recognition in Noise Ratio: Baha Attract Versus Sound Processor on Softband | 24 months: Speech in Noise | -0.739 change in SNR dB | Standard Deviation 4.106 |
Comparison: 6 months: Speech in Noise with Baha Attract vs Softbandp-value: 0.46Fisher's non-parametric permutation test
Comparison: 12 months: Speech in Noise with Baha Attract vs Softbandp-value: 0.19Fisher's non-parametric permutation test
Comparison: 24 months: Speech in Noise with Baha Attract vs Softbandp-value: 0.31Fisher's non-parametric permutation test
Secondary
Adaptive Speech Recognition in Noise Ratio: Unaided Versus Baha Attract
The change of hearing performance with the Baha Attract System compared to the pre-operative unaided situation; Adaptive speech recognition in noise measured as signal to noise ratio The adaptive speech test in noise was conducted using validated lists of phonetically balanced sentences, with speech presented from the front (0 degrees azimuth) and noise from the back (180 degrees azimuth). The noise was kept constant at 65 dB SPL, and the speech was adapted in 2 dB steps to establish the speech-to-noise ratio (SNR) providing a 50% level of understanding. A ratio of 1 reflects the ability to correctly hear sentences at 65 dB, in the presence of 65 dB background noise. A lower ratio than 1 reflects the ability to correctly hear sentences below 65 dB. A ratio higher than 1 reflects the ability to correctly hear sentences presented above 65 dB. Manchester and Birmingham are excluded from this analysis due to incorrect set up.
Time frame: Baseline (unaided) before surgery, 6, 12 and 24 months after surgery
Population: Intention-to-Treat (ITT) population; includes all patient who received the surgical intervention.~Adaptive Speech in Noise analysis excluded subjects from Birmingham and Manchester clinics due to incorrect set up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baha Attract System | Adaptive Speech Recognition in Noise Ratio: Unaided Versus Baha Attract | SNR 6 months, Baha Attract vs Unaided | -4.30 dB | Standard Deviation 5.64 |
| Baha Attract System | Adaptive Speech Recognition in Noise Ratio: Unaided Versus Baha Attract | SNR 24 months, Baha Attract vs Unaided | -4.47 dB | Standard Deviation 6.11 |
| Baha Attract System | Adaptive Speech Recognition in Noise Ratio: Unaided Versus Baha Attract | SNR 12 months, Baha Attract vs Unaided | 4.79 dB | Standard Deviation 6.17 |
Comparison: Speech in Noise, 6 months Baha Attract vs Unaidedp-value: <0.0001Fisher's non-parametric permutation test
Comparison: Speech in Noise, 12 months Baha Attract vs Unaidedp-value: <0.0001Fisher's non-parametric permutation test
Comparison: Speech in Noise, 24 months Baha Attract vs Unaidedp-value: <0.0001Fisher's non-parametric permutation test
Secondary
Health Utility Index (HUI)
Change of health status and health related quality of life using the generic quality of life scale Health Utilities Index (HUI3) when wearing Baha Attract System compared to the pre-operative unaided situation. A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The change from unaided to aided hearing is presented. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life. HUI score of 1 (maximum) describes a state of perfect health. HUI score of 0 describes a state of dead. A negative score of Comprehensive Health State describes a state worse than dead.
Time frame: Baseline (unaided) before surgery, 6 and 24 months after surgery
Population: Intention-to-Treat (ITT) population; includes all patients who received the surgical intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baha Attract System | Health Utility Index (HUI) | 6 months: Comprehensive health state | 0.063 units on a scale | Standard Deviation 0.249 |
| Baha Attract System | Health Utility Index (HUI) | 6 months: Vision | -0.003 units on a scale | Standard Deviation 0.033 |
| Baha Attract System | Health Utility Index (HUI) | 6 months: Cognition | 0.005 units on a scale | Standard Deviation 0.158 |
| Baha Attract System | Health Utility Index (HUI) | 6 months: Pain | 0.020 units on a scale | Standard Deviation 0.123 |
| Baha Attract System | Health Utility Index (HUI) | 24 months: Comprehensive health state | 0.069 units on a scale | Standard Deviation 0.24 |
| Baha Attract System | Health Utility Index (HUI) | 24 months: Vision | 0.002 units on a scale | Standard Deviation 0.015 |
| Baha Attract System | Health Utility Index (HUI) | 24 months: Dexterity | -0.025 units on a scale | Standard Deviation 0.151 |
| Baha Attract System | Health Utility Index (HUI) | 24 months: Emotion | 0.014 units on a scale | Standard Deviation 0.089 |
| Baha Attract System | Health Utility Index (HUI) | 24 months: Cognition | 0.003 units on a scale | Standard Deviation 0.134 |
| Baha Attract System | Health Utility Index (HUI) | 24 months: Pain | 0.040 units on a scale | Standard Deviation 0.117 |
| Baha Attract System | Health Utility Index (HUI) | 6 months: Hearing | 0.111 units on a scale | Standard Deviation 0.321 |
| Baha Attract System | Health Utility Index (HUI) | 6 months: Speech | 0.045 units on a scale | Standard Deviation 0.153 |
| Baha Attract System | Health Utility Index (HUI) | 6 months: Ambulation | -0.016 units on a scale | Standard Deviation 0.067 |
| Baha Attract System | Health Utility Index (HUI) | 6 months: Dexterity | -0.021 units on a scale | Standard Deviation 0.108 |
| Baha Attract System | Health Utility Index (HUI) | 6 months: Emotion | 0.017 units on a scale | Standard Deviation 0.152 |
| Baha Attract System | Health Utility Index (HUI) | 24 months: Hearing | 0.119 units on a scale | Standard Deviation 0.358 |
| Baha Attract System | Health Utility Index (HUI) | 24 months: Speech | 0.051 units on a scale | Standard Deviation 0.135 |
| Baha Attract System | Health Utility Index (HUI) | 24 months: Ambulation | -0.015 units on a scale | Standard Deviation 0.076 |
Comparison: 6 months change in Comprehensive health statep-value: 0.088Fisher's non-parametric permutation test
Comparison: 6 months change in Visionp-value: 0.88Fisher's non-parametric permutation test
Comparison: 6 months change in Hearingp-value: 0.02Fisher's non-parametric permutation test
Comparison: 6 months change in Speechp-value: 0.039Fisher's non-parametric permutation test
Comparison: 6 months change in Ambulationp-value: 0.25Fisher's non-parametric permutation test
Comparison: 6 months change in Dexterityp-value: 0.38Fisher's non-parametric permutation test
Comparison: 6 months change in Emotionp-value: 0.43Fisher's non-parametric permutation test
Comparison: 6 months change in Cognitionp-value: 0.85Fisher's non-parametric permutation test
Comparison: 6 months change in Painp-value: 0.25Fisher's non-parametric permutation test
Comparison: 24 months change in Comprehensive health statep-value: 0.088Fisher's non-parametric permutation test
Comparison: 24 months change in Visionp-value: 0.63Fisher's non-parametric permutation test
Comparison: 24 months change in Hearingp-value: 0.045Fisher's non-parametric permutation test
Comparison: 24 months change in Speechp-value: 0.016Fisher's non-parametric permutation test
Comparison: 24 months change in Ambulationp-value: 0.25Fisher's non-parametric permutation test
Comparison: 24 months change in Dexterityp-value: 0.5Wilcoxan Signed Rank Test
Comparison: 24 months change in Emotionp-value: 0.29Fisher's non-parametric permutation test
Comparison: 24 months change in Cognitionp-value: 0.92Fisher's non-parametric permutation test
Comparison: 24 months change in Painp-value: 0.02Fisher's non-parametric permutation test
Secondary
Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband
The change of hearing performance with the Baha Attract System (aided) from the aided hearing performance with Sound processor on a Softband before surgery; measured as free-field hearing tests: Threshold audiometry at individual frequencies: 250, 500, 1000, 2000, 3000, 4000, 6000 Hz. The units reported for threshold audiometry are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Time frame: Baseline (aided) before surgery, 12 months after surgery
Population: Intention-to-Treat population (ITT); includes all subjects who received the surgical intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baha Attract System | Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband | 12 months: Change of Threshold value at 250 Hz | -2.55 dB | Standard Deviation 11.15 |
| Baha Attract System | Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband | 12 months: Change of Threshold value at 500 Hz | -2.84 dB | Standard Deviation 10.74 |
| Baha Attract System | Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband | 12 months: Change of Threshold value at 3000 Hz | 4.02 dB | Standard Deviation 11.53 |
| Baha Attract System | Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband | 12 months: Change of Threshold value at 1000 Hz | -0.392 dB | Standard Deviation 6.989 |
| Baha Attract System | Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband | 12 months: Change of Threshold value at 2000 Hz | 0.392 dB | Standard Deviation 9.265 |
| Baha Attract System | Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband | 12 months: Change of Threshold value at 4000 Hz | 3.63 dB | Standard Deviation 11.84 |
| Baha Attract System | Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband | 12 months: Change of Threshold value at 6000 Hz | 5.59 dB | Standard Deviation 11.52 |
Comparison: 250Hz: 12 months with Baha Attract vs Softbandp-value: 0.11Fisher's non-parametric permutation test
Comparison: 500Hz: 12 months with Baha Attract vs Softbandp-value: 0.066Fisher's non-parametric permutation test
Comparison: 1000Hz: 12 months with Baha Attract vs Softbandp-value: 0.71Fisher's non-parametric permutation test
Comparison: 2000Hz: 12 months with Baha Attract vs Softbandp-value: 0.78Fisher's non-parametric permutation test
Comparison: 3000Hz: 12 months with Baha Attract vs Softbandp-value: 0.015Fisher's non-parametric permutation test
Comparison: 4000Hz: 12 months with Baha Attract vs Softbandp-value: 0.035Fisher's non-parametric permutation test
Comparison: 6000Hz: 12 months with Baha Attract vs Softbandp-value: 0.0013Fisher's non-parametric permutation test
Secondary
Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband
The change of hearing performance with the Baha Attract System (aided) from the aided hearing performance with Sound processor on a Softband before surgery; measured as free-field hearing tests: Threshold audiometry at individual frequencies: 250, 500, 1000, 2000, 3000, 4000, 6000 Hz. The units reported for threshold audiometry are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Time frame: Baseline (aided) before surgery, 24 months after surgery
Population: Intention-to-Treat population (ITT); includes all subjects who received the surgical intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baha Attract System | Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband | 24 months: Change of Threshold value at 1000 Hz | -1.20 dB | Standard Deviation 6.34 |
| Baha Attract System | Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband | 24 months: Change of Threshold value at 2000 Hz | -0.761 dB | Standard Deviation 8.69 |
| Baha Attract System | Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband | 24 months: Change of Threshold value at 6000 Hz | 5.22 dB | Standard Deviation 11.72 |
| Baha Attract System | Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband | 24 months: Change of Threshold value at 250 Hz | -3.67 dB | Standard Deviation 8.35 |
| Baha Attract System | Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband | 24 months: Change of Threshold value at 500 Hz | -1.74 dB | Standard Deviation 10.23 |
| Baha Attract System | Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband | 24 months: Change of Threshold value at 3000 Hz | 2.61 dB | Standard Deviation 9.23 |
| Baha Attract System | Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband | 24 months: Change of Threshold value at 4000 Hz | 3.15 dB | Standard Deviation 11.17 |
Comparison: 250Hz: 24 months with Baha Attract vs Softbandp-value: 0.0051Fisher's non-parametric permutation test
Comparison: 500Hz: 24 months with Baha Attract vs Softbandp-value: 0.26Fisher's non-parametric permutation test
Comparison: 1000Hz: 24 months with Baha Attract vs Softbandp-value: 0.22Fisher's non-parametric permutation test
Comparison: 2000Hz: 24 months with Baha Attract vs Softbandp-value: 0.57Fisher's non-parametric permutation test
Comparison: 3000Hz: 24 months with Baha Attract vs Softbandp-value: 0.064Fisher's non-parametric permutation test
Comparison: 4000Hz: 24 months with Baha Attract vs Softbandp-value: 0.064Fisher's non-parametric permutation test
Comparison: 6000Hz: 24 months with Baha Attract vs Softbandp-value: 0.0051Fisher's non-parametric permutation test
Secondary
Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband
The change of hearing performance with the Baha Attract System (aided) from the aided hearing performance with Sound processor on a Softband before surgery; measured as free-field hearing tests: Threshold audiometry at individual frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 Hz. The units reported for threshold audiometry are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Time frame: Baseline (aided) before surgery, 6 months after surgery
Population: Intention-to-Treat population (ITT); includes all subjects who received the surgical intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baha Attract System | Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband | 6 months: Change of Threshold value at 250 Hz | -1.30 dB | Standard Deviation 9.77 |
| Baha Attract System | Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband | 6 months: Change of Threshold value at 500 Hz | -4.17 dB | Standard Deviation 7.99 |
| Baha Attract System | Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband | 6 months: Change of Threshold value at 1000 Hz | -1.11 dB | Standard Deviation 6.49 |
| Baha Attract System | Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband | 6 months: Change of Threshold value at 2000 Hz | -0.463 dB | Standard Deviation 7.022 |
| Baha Attract System | Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband | 6 months: Change of Threshold value at 3000 Hz | 2.69 dB | Standard Deviation 9.4 |
| Baha Attract System | Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband | 6 months: Change of Threshold value at 4000 Hz | 3.24 dB | Standard Deviation 9.07 |
| Baha Attract System | Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband | 6 months: Change of Threshold value at 6000 Hz | 5.56 dB | Standard Deviation 9.6 |
Comparison: 250Hz: 6 months with Baha Attract vs Softbandp-value: 0.34Fisher's non-parametric permutation test
Comparison: 500Hz: 6 months with Baha Attract vs Softbandp-value: 0.0004Fisher's non-parametric permutation test
Comparison: 1000Hz: 6 months with Baha Attract vs Softbandp-value: 0.22Fisher's non-parametric permutation test
Comparison: 2000Hz: 6 months with Baha Attract vs Softbandp-value: 0.64Fisher's non-parametric permutation test
Comparison: 3000Hz: 6 months with Baha Attract vs Softbandp-value: 0.039Fisher's non-parametric permutation test
Comparison: 4000Hz: 6 months with Baha Attract vs Softbandp-value: 0.012Fisher's non-parametric permutation test
Comparison: 6000Hz: 6 months with Baha Attract vs Softbandp-value: <0.0001Fisher's non-parametric permutation test
Secondary
Hearing Performance: Threshold Audiometry PTA4: Sound Processor on Softband Versus Baha Attract
The change of hearing performance with the Baha Attract System (aided) from the aided hearing performance, sound processor on a softband, before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz) The units reported for PTA4 are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.
Time frame: Baseline before surgery, 6, 12 and 24 months after surgery
Population: Intention-to-Treat (ITT) population; includes all subjects who received the surgical intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baha Attract System | Hearing Performance: Threshold Audiometry PTA4: Sound Processor on Softband Versus Baha Attract | 12 months vs Softband: PTA4 | 0.196 dB | Standard Deviation 6.719 |
| Baha Attract System | Hearing Performance: Threshold Audiometry PTA4: Sound Processor on Softband Versus Baha Attract | 24 months vs Softband: PTA4 | -0.136 dB | Standard Deviation 6.472 |
| Baha Attract System | Hearing Performance: Threshold Audiometry PTA4: Sound Processor on Softband Versus Baha Attract | 6 months vs Softband: PTA4 | -0.62 dB | Standard Deviation 5.138 |
Comparison: 6 months with Baha Attract vs Softband: change in PTA4p-value: 0.38Fisher's non-parametric permutation test
Comparison: 12 months with Baha Attract vs Softband: change in PTA4p-value: 0.84Fisher's non-parametric permutation test
Comparison: 24 months with Baha Attract vs Softband: change in PTA4p-value: 0.89Fisher's non-parametric permutation test
Secondary
Implant Stability
Implant Stability Quotient - ISQ, a scale from 1 to 100, where 100 represent the highest stability
Time frame: Visit 2 (surgery)
Population: Intention-to-treat (ITT) population; includes all patients who received surgical intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baha Attract System | Implant Stability | 77.3 units on a scale | Standard Deviation 9 |
Secondary
Magnetic Force
To investigate if the magnetic force required for sound processor magnet retention will change over time
Time frame: 4, 6, 12 weeks, 6, 12 and 24 months
Population: Intention-to-Treat (ITT) population; includes all patients who received surgical intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baha Attract System | Magnetic Force | 4 weeks | 1.01 Newton | Standard Deviation 0.4 |
| Baha Attract System | Magnetic Force | 6 weeks | 1.07 Newton | Standard Deviation 0.33 |
| Baha Attract System | Magnetic Force | 12 weeks | 1.15 Newton | Standard Deviation 0.41 |
| Baha Attract System | Magnetic Force | 6 months | 1.16 Newton | Standard Deviation 0.42 |
| Baha Attract System | Magnetic Force | 12 months | 1.15 Newton | Standard Deviation 0.38 |
| Baha Attract System | Magnetic Force | 24 months | 1.09 Newton | Standard Deviation 0.41 |
Secondary
Numbness When Tested With a Cotton Swab
Degree of numbness when tested with a Cotton Swab
Time frame: Day 10, Week 4, Week 6, Week 12, Month 6, Month 12, Month 24
Population: Safety population; includes all patients who received the surgical intervention.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Baha Attract System | Numbness When Tested With a Cotton Swab | Day 10: Numbness tested with a Cotton Swab | No Numbness | 13 Participants |
| Baha Attract System | Numbness When Tested With a Cotton Swab | Day 10: Numbness tested with a Cotton Swab | Numbness within 2 cm from implant | 9 Participants |
| Baha Attract System | Numbness When Tested With a Cotton Swab | Day 10: Numbness tested with a Cotton Swab | Numbness within & beyond 2cm from Implant | 32 Participants |
| Baha Attract System | Numbness When Tested With a Cotton Swab | Week 4: Numbness tested with a Cotton Swab | No Numbness | 18 Participants |
| Baha Attract System | Numbness When Tested With a Cotton Swab | Week 4: Numbness tested with a Cotton Swab | Numbness within 2 cm from implant | 6 Participants |
| Baha Attract System | Numbness When Tested With a Cotton Swab | Week 4: Numbness tested with a Cotton Swab | Numbness within & beyond 2cm from Implant | 30 Participants |
| Baha Attract System | Numbness When Tested With a Cotton Swab | Week 6: Numbness tested with a Cotton Swab | No Numbness | 23 Participants |
| Baha Attract System | Numbness When Tested With a Cotton Swab | Week 6: Numbness tested with a Cotton Swab | Numbness within 2 cm from implant | 2 Participants |
| Baha Attract System | Numbness When Tested With a Cotton Swab | Week 6: Numbness tested with a Cotton Swab | Numbness within & beyond 2cm from Implant | 28 Participants |
| Baha Attract System | Numbness When Tested With a Cotton Swab | Week 12: Numbness tested with a Cotton Swab | No Numbness | 31 Participants |
| Baha Attract System | Numbness When Tested With a Cotton Swab | Week 12: Numbness tested with a Cotton Swab | Numbness within 2 cm from implant | 6 Participants |
| Baha Attract System | Numbness When Tested With a Cotton Swab | Week 12: Numbness tested with a Cotton Swab | Numbness within & beyond 2cm from Implant | 16 Participants |
| Baha Attract System | Numbness When Tested With a Cotton Swab | Month 6: Numbness tested with a Cotton Swab | No Numbness | 43 Participants |
| Baha Attract System | Numbness When Tested With a Cotton Swab | Month 6: Numbness tested with a Cotton Swab | Numbness within 2 cm from implant | 2 Participants |
| Baha Attract System | Numbness When Tested With a Cotton Swab | Month 6: Numbness tested with a Cotton Swab | Numbness within & beyond 2cm from Implant | 7 Participants |
| Baha Attract System | Numbness When Tested With a Cotton Swab | Month 12: Numbness tested with a Cotton Swab | No Numbness | 44 Participants |
| Baha Attract System | Numbness When Tested With a Cotton Swab | Month 12: Numbness tested with a Cotton Swab | Numbness within 2 cm from implant | 3 Participants |
| Baha Attract System | Numbness When Tested With a Cotton Swab | Month 12: Numbness tested with a Cotton Swab | Numbness within & beyond 2cm from Implant | 5 Participants |
| Baha Attract System | Numbness When Tested With a Cotton Swab | Month 24: Numbness tested with a Cotton Swab | No Numbness | 42 Participants |
| Baha Attract System | Numbness When Tested With a Cotton Swab | Month 24: Numbness tested with a Cotton Swab | Numbness within 2 cm from implant | 3 Participants |
| Baha Attract System | Numbness When Tested With a Cotton Swab | Month 24: Numbness tested with a Cotton Swab | Numbness within & beyond 2cm from Implant | 1 Participants |
Secondary
Numbness When Tested With a Pin
Degree of numbness when tested with a pin
Time frame: Day 10, Week 4, Week 6, Week 12, Month 6, Month 12, Month 24
Population: Safety population; includes all patients who received the surgical intervention.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Baha Attract System | Numbness When Tested With a Pin | Week 12: Numbness tested with a pin | No Numbness | 33 Participants |
| Baha Attract System | Numbness When Tested With a Pin | Week 12: Numbness tested with a pin | Numbness within 2cm of Implant | 5 Participants |
| Baha Attract System | Numbness When Tested With a Pin | Week 12: Numbness tested with a pin | Numbness within & beyond 2cm from Implant | 15 Participants |
| Baha Attract System | Numbness When Tested With a Pin | Month 6: Numbness tested with a Pin | No Numbness | 42 Participants |
| Baha Attract System | Numbness When Tested With a Pin | Month 6: Numbness tested with a Pin | Numbness within 2cm of Implant | 3 Participants |
| Baha Attract System | Numbness When Tested With a Pin | Month 6: Numbness tested with a Pin | Numbness within & beyond 2cm from Implant | 7 Participants |
| Baha Attract System | Numbness When Tested With a Pin | Month 12: Numbness tested with a Pin | No Numbness | 45 Participants |
| Baha Attract System | Numbness When Tested With a Pin | Month 12: Numbness tested with a Pin | Numbness within 2cm of Implant | 3 Participants |
| Baha Attract System | Numbness When Tested With a Pin | Month 12: Numbness tested with a Pin | Numbness within & beyond 2cm from Implant | 4 Participants |
| Baha Attract System | Numbness When Tested With a Pin | Month 24: Numbness tested with a Pin | No Numbness | 45 Participants |
| Baha Attract System | Numbness When Tested With a Pin | Month 24: Numbness tested with a Pin | Numbness within 2cm of Implant | 0 Participants |
| Baha Attract System | Numbness When Tested With a Pin | Month 24: Numbness tested with a Pin | Numbness within & beyond 2cm from Implant | 1 Participants |
| Baha Attract System | Numbness When Tested With a Pin | Day 10: Numbness tested with a Pin | No Numbness | 12 Participants |
| Baha Attract System | Numbness When Tested With a Pin | Day 10: Numbness tested with a Pin | Numbness within 2cm of Implant | 9 Participants |
| Baha Attract System | Numbness When Tested With a Pin | Day 10: Numbness tested with a Pin | Numbness within & beyond 2cm from Implant | 33 Participants |
| Baha Attract System | Numbness When Tested With a Pin | Week 4: Numbness tested with a pin | No Numbness | 15 Participants |
| Baha Attract System | Numbness When Tested With a Pin | Week 4: Numbness tested with a pin | Numbness within 2cm of Implant | 7 Participants |
| Baha Attract System | Numbness When Tested With a Pin | Week 4: Numbness tested with a pin | Numbness within & beyond 2cm from Implant | 32 Participants |
| Baha Attract System | Numbness When Tested With a Pin | Week 6: Numbness tested with a pin | No Numbness | 21 Participants |
| Baha Attract System | Numbness When Tested With a Pin | Week 6: Numbness tested with a pin | Numbness within 2cm of Implant | 3 Participants |
| Baha Attract System | Numbness When Tested With a Pin | Week 6: Numbness tested with a pin | Numbness within & beyond 2cm from Implant | 29 Participants |
Secondary
Pain & Discomfort
Degree of pain and discomfort.
Time frame: Week 6, Week 12, Month 6, Month 12, Month 24
Population: Safety population; includes all patients who received the surgical intervention.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Baha Attract System | Pain & Discomfort | Week 6 | No Discomfort or Pain | 21 Participants |
| Baha Attract System | Pain & Discomfort | Week 6 | Slight Discomfort or Pain | 15 Participants |
| Baha Attract System | Pain & Discomfort | Week 6 | Discomfort or Pain | 15 Participants |
| Baha Attract System | Pain & Discomfort | Week 6 | Excessive Discomfort or Pain | 2 Participants |
| Baha Attract System | Pain & Discomfort | Week 12 | No Discomfort or Pain | 24 Participants |
| Baha Attract System | Pain & Discomfort | Week 12 | Slight Discomfort or Pain | 16 Participants |
| Baha Attract System | Pain & Discomfort | Week 12 | Discomfort or Pain | 11 Participants |
| Baha Attract System | Pain & Discomfort | Week 12 | Excessive Discomfort or Pain | 2 Participants |
| Baha Attract System | Pain & Discomfort | Month 6 | No Discomfort or Pain | 33 Participants |
| Baha Attract System | Pain & Discomfort | Month 6 | Slight Discomfort or Pain | 15 Participants |
| Baha Attract System | Pain & Discomfort | Month 6 | Discomfort or Pain | 5 Participants |
| Baha Attract System | Pain & Discomfort | Month 6 | Excessive Discomfort or Pain | 0 Participants |
| Baha Attract System | Pain & Discomfort | Month 12 | No Discomfort or Pain | 37 Participants |
| Baha Attract System | Pain & Discomfort | Month 12 | Slight Discomfort or Pain | 11 Participants |
| Baha Attract System | Pain & Discomfort | Month 12 | Discomfort or Pain | 4 Participants |
| Baha Attract System | Pain & Discomfort | Month 12 | Excessive Discomfort or Pain | 0 Participants |
| Baha Attract System | Pain & Discomfort | Month 24 | No Discomfort or Pain | 40 Participants |
| Baha Attract System | Pain & Discomfort | Month 24 | Slight Discomfort or Pain | 4 Participants |
| Baha Attract System | Pain & Discomfort | Month 24 | Discomfort or Pain | 3 Participants |
| Baha Attract System | Pain & Discomfort | Month 24 | Excessive Discomfort or Pain | 0 Participants |
Secondary
Sound Processor Magnet Choice
To investigate how sound processor magnet choice will change over time. Six different magnetic strength could be chosen; SPM 1 had the lowest strength and SPM 6 the the highest.
Time frame: 4, 6, 12 weeks, 6, 12 and 24 months
Population: Intention-to-Treat (ITT) population; includes all patients who received surgical intervention at week 4. At week 6, 12 and month 6, 12 and 24 one patient had left the study.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Baha Attract System | Sound Processor Magnet Choice | Month 24 | SPM 4 | 5 Participants |
| Baha Attract System | Sound Processor Magnet Choice | Month 24 | SPM 3 | 17 Participants |
| Baha Attract System | Sound Processor Magnet Choice | Month 24 | SPM 5 | 8 Participants |
| Baha Attract System | Sound Processor Magnet Choice | Week 4 | SPM 6 | 19 Participants |
| Baha Attract System | Sound Processor Magnet Choice | Week 4 | SPM 5 | 19 Participants |
| Baha Attract System | Sound Processor Magnet Choice | Week 4 | SPM 4 | 9 Participants |
| Baha Attract System | Sound Processor Magnet Choice | Week 4 | SPM 3 | 6 Participants |
| Baha Attract System | Sound Processor Magnet Choice | Week 4 | SPM 2 | 1 Participants |
| Baha Attract System | Sound Processor Magnet Choice | Week 4 | SPM 1 | 0 Participants |
| Baha Attract System | Sound Processor Magnet Choice | Week 6 | SPM 6 | 11 Participants |
| Baha Attract System | Sound Processor Magnet Choice | Week 6 | SPM 5 | 10 Participants |
| Baha Attract System | Sound Processor Magnet Choice | Week 6 | SPM 4 | 16 Participants |
| Baha Attract System | Sound Processor Magnet Choice | Week 6 | SPM 3 | 13 Participants |
| Baha Attract System | Sound Processor Magnet Choice | Week 6 | SPM 2 | 2 Participants |
| Baha Attract System | Sound Processor Magnet Choice | Week 6 | SPM 1 | 1 Participants |
| Baha Attract System | Sound Processor Magnet Choice | Week 12 | SPM 6 | 6 Participants |
| Baha Attract System | Sound Processor Magnet Choice | Week 12 | SPM 5 | 12 Participants |
| Baha Attract System | Sound Processor Magnet Choice | Week 12 | SPM 4 | 11 Participants |
| Baha Attract System | Sound Processor Magnet Choice | Week 12 | SPM 3 | 15 Participants |
| Baha Attract System | Sound Processor Magnet Choice | Week 12 | SPM 2 | 9 Participants |
| Baha Attract System | Sound Processor Magnet Choice | Week 12 | SPM 1 | 0 Participants |
| Baha Attract System | Sound Processor Magnet Choice | Month 6 | SPM 6 | 5 Participants |
| Baha Attract System | Sound Processor Magnet Choice | Month 6 | SPM 5 | 9 Participants |
| Baha Attract System | Sound Processor Magnet Choice | Month 6 | SPM 4 | 12 Participants |
| Baha Attract System | Sound Processor Magnet Choice | Month 6 | SPM 3 | 18 Participants |
| Baha Attract System | Sound Processor Magnet Choice | Month 6 | SPM 2 | 9 Participants |
| Baha Attract System | Sound Processor Magnet Choice | Month 6 | SPM 1 | 0 Participants |
| Baha Attract System | Sound Processor Magnet Choice | Month 12 | SPM 6 | 6 Participants |
| Baha Attract System | Sound Processor Magnet Choice | Month 12 | SPM 5 | 11 Participants |
| Baha Attract System | Sound Processor Magnet Choice | Month 12 | SPM 4 | 12 Participants |
| Baha Attract System | Sound Processor Magnet Choice | Month 12 | SPM 3 | 14 Participants |
| Baha Attract System | Sound Processor Magnet Choice | Month 12 | SPM 2 | 8 Participants |
| Baha Attract System | Sound Processor Magnet Choice | Month 12 | SPM 1 | 1 Participants |
| Baha Attract System | Sound Processor Magnet Choice | Month 24 | SPM 6 | 5 Participants |
| Baha Attract System | Sound Processor Magnet Choice | Month 24 | SPM 2 | 9 Participants |
| Baha Attract System | Sound Processor Magnet Choice | Month 24 | SPM 1 | 2 Participants |
Secondary
Speech in Quiet: Baha Attract Versus Sound Processor on Softband
The change of hearing performance with the Baha Attract System at 6 months compared to the pre-operative aided situation with the Sound Processor on a softband; Speech in quiet at 50, 65 and 80dB. Speech in Quiet is a measure of percentage of correct words. A higher score reflects a higher percentage of correct words.
Time frame: Baseline (aided) before surgery, 6, 12 and 24 months after surgery
Population: Intention-to-Treat (ITT) population; includes all patients who received the surgical intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baha Attract System | Speech in Quiet: Baha Attract Versus Sound Processor on Softband | 6 months: Speech in quiet at 50dB | 2.74 Change of % correct words at the dB leve | Standard Deviation 29.94 |
| Baha Attract System | Speech in Quiet: Baha Attract Versus Sound Processor on Softband | 6 months: Speech in quiet at 65dB | -2.11 Change of % correct words at the dB leve | Standard Deviation 10.62 |
| Baha Attract System | Speech in Quiet: Baha Attract Versus Sound Processor on Softband | 6 months: Speech in quiet at 80dB | -0.33 Change of % correct words at the dB leve | Standard Deviation 5 |
| Baha Attract System | Speech in Quiet: Baha Attract Versus Sound Processor on Softband | 12 months: Speech in quiet at 65dB | -2.69 Change of % correct words at the dB leve | Standard Deviation 11.16 |
| Baha Attract System | Speech in Quiet: Baha Attract Versus Sound Processor on Softband | 24 months: Speech in quiet at 65dB | -5.67 Change of % correct words at the dB leve | Standard Deviation 16.48 |
| Baha Attract System | Speech in Quiet: Baha Attract Versus Sound Processor on Softband | 24 months: Speech in quiet at 80dB | -0.696 Change of % correct words at the dB leve | Standard Deviation 8.178 |
| Baha Attract System | Speech in Quiet: Baha Attract Versus Sound Processor on Softband | 12 months: Speech in quiet at 50dB | 0.373 Change of % correct words at the dB leve | Standard Deviation 27.201 |
| Baha Attract System | Speech in Quiet: Baha Attract Versus Sound Processor on Softband | 12 months: Speech in quiet at 80dB | -0.961 Change of % correct words at the dB leve | Standard Deviation 8.457 |
| Baha Attract System | Speech in Quiet: Baha Attract Versus Sound Processor on Softband | 24 months: Speech in quiet at 50dB | -11.6 Change of % correct words at the dB leve | Standard Deviation 32.6 |
Comparison: 6 months Speech in Quiet at 50dBp-value: 0.43Fisher's non-parametric permutation test
Comparison: 6 months Speech in Quiet at 65dBp-value: 0.16Fisher's non-parametric permutation test
Comparison: 6 months Speech in Quiet at 80dBp-value: 0.65Fisher's non-parametric permutation test
Comparison: 12 months Speech in Quiet at 50dBp-value: 0.93Fisher's non-parametric permutation test
Comparison: 12 months Speech in Quiet at 65dBp-value: 0.094Fisher's non-parametric permutation test
Comparison: 12 months Speech in Quiet at 80dBp-value: 0.44Fisher's non-parametric permutation test
Comparison: 24 months Speech in Quiet at 50dBp-value: 0.021Fisher's non-parametric permutation test
Comparison: 24 months Speech in Quiet at 65dBp-value: 0.024Fisher's non-parametric permutation test
Comparison: 24 months Speech in Quiet at 80dBp-value: 0.59Fisher's non-parametric permutation test
Secondary
Speech in Quiet, Baha Attract Versus Unaided
The change of hearing performance with the Baha Attract System at 6, 12 and 24 months compared to the pre-operative unaided situation; Speech in quiet at 50, 65 and 80dB. Speech in Quiet is a measure of percentage of correct words. A higher score reflects a higher percentage of correct words.
Time frame: Baseline before surgery, 6, 12 and 24 months after surgery
Population: Intention-to-Treat (ITT) population; includes all patients who received the surgical intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baha Attract System | Speech in Quiet, Baha Attract Versus Unaided | 6 months: Speech in quiet at 50dB | 52.1 Change of % correct words at the dB leve | Standard Deviation 29.2 |
| Baha Attract System | Speech in Quiet, Baha Attract Versus Unaided | 6 months: Speech in quiet at 65dB | 43.4 Change of % correct words at the dB leve | Standard Deviation 31.5 |
| Baha Attract System | Speech in Quiet, Baha Attract Versus Unaided | 6 months: Speech in quiet at 80dB | 13.3 Change of % correct words at the dB leve | Standard Deviation 20.6 |
| Baha Attract System | Speech in Quiet, Baha Attract Versus Unaided | 12 months: Speech in quiet at 50dB | 50.7 Change of % correct words at the dB leve | Standard Deviation 30.2 |
| Baha Attract System | Speech in Quiet, Baha Attract Versus Unaided | 12 months: Speech in quiet at 65dB | 45.5 Change of % correct words at the dB leve | Standard Deviation 31.4 |
| Baha Attract System | Speech in Quiet, Baha Attract Versus Unaided | 12 months: Speech in quiet at 80dB | 13.9 Change of % correct words at the dB leve | Standard Deviation 21.2 |
| Baha Attract System | Speech in Quiet, Baha Attract Versus Unaided | 24 months: Speech in quiet at 50dB | 40.4 Change of % correct words at the dB leve | Standard Deviation 33.3 |
| Baha Attract System | Speech in Quiet, Baha Attract Versus Unaided | 24 months: Speech in quiet at 65dB | 43.3 Change of % correct words at the dB leve | Standard Deviation 29.9 |
| Baha Attract System | Speech in Quiet, Baha Attract Versus Unaided | 24 months: Speech in quiet at 80dB | 14.0 Change of % correct words at the dB leve | Standard Deviation 20.7 |
Comparison: 6 months: Speech in quiet at 50dBp-value: <0.0001Fisher's non-parametric permutation test
Comparison: 6 months: Speech in quiet at 65dBp-value: <0.0001Fisher's non-parametric permutation test
Comparison: 6 months: Speech in quiet at 80dBp-value: <0.0001Fisher's non-parametric permutation test
Comparison: 12 months: Speech in quiet at 50dBp-value: <0.0001Fisher's non-parametric permutation test
Comparison: 12 months: Speech in quiet at 65dBp-value: <0.0001Fisher's non-parametric permutation test
Comparison: 12 months: Speech in quiet at 80dBp-value: <0.0001Fisher's non-parametric permutation test
Comparison: 24 months: Speech in quiet at 50dBp-value: <0.0001Fisher's non-parametric permutation test
Comparison: 24 months: Speech in quiet at 65dBp-value: <0.0001Fisher's non-parametric permutation test
Comparison: 24 months: Speech in quiet at 80dBp-value: <0.0001Fisher's non-parametric permutation test
Secondary
Speech, Spatial and Qualities of Hearing Scale (SSQ)
Measuring change of speech, spatial and hearing experiences with the Baha Attract System from the pre-operative unaided situation. A scale from 0 to 10, where 0 represents can not hear at all, and 10 hear perfectly. The change from unaided to aided hearing is presented. A positive value indicates improved hearing, a negative value indicates impaired hearing.
Time frame: Baseline before surgery, 6 and 24 months after surgery
Population: Intention-to-Treat (ITT) population; includes all patient who received the surgical intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baha Attract System | Speech, Spatial and Qualities of Hearing Scale (SSQ) | Qualities: Change from pre-op to 24 months | 1.30 units on scale | Standard Deviation 1.39 |
| Baha Attract System | Speech, Spatial and Qualities of Hearing Scale (SSQ) | Speech: Change from pre-op to 6 months | 2.49 units on scale | Standard Deviation 1.67 |
| Baha Attract System | Speech, Spatial and Qualities of Hearing Scale (SSQ) | Spatial: Change from pre-op to 6 months | 1.87 units on scale | Standard Deviation 1.9 |
| Baha Attract System | Speech, Spatial and Qualities of Hearing Scale (SSQ) | Qualities: Change from pre-op to 6 months | 1.68 units on scale | Standard Deviation 1.36 |
| Baha Attract System | Speech, Spatial and Qualities of Hearing Scale (SSQ) | Speech: Change from pre-op to 24 months | 2.07 units on scale | Standard Deviation 1.57 |
| Baha Attract System | Speech, Spatial and Qualities of Hearing Scale (SSQ) | Spatial: Change from pre-op to 24 months | 1.36 units on scale | Standard Deviation 1.74 |
Comparison: Speech: Change from pre-op to 6 monthsp-value: <0.0001Fisher's non-parametric permutation test
Comparison: Spatial: Change from pre-op to 6 monthsp-value: <0.0001Fisher's non-parametric permutation test
Comparison: Qualities: Change from pre-op to 6 monthsp-value: <0.0001Fisher's non-parametric permutation test
Comparison: Speech: Change from pre-op to 24 monthsp-value: <0.0001Fisher's non-parametric permutation test
Comparison: Spatial: Change from pre-op to 24 monthsp-value: <0.0001Fisher's non-parametric permutation test
Comparison: Qualities: Change from pre-op to 24 monthsp-value: <0.0001Fisher's non-parametric permutation test
Secondary
Time to Perform Surgery
Time of first incision to time of last suture
Time frame: Visit 2 (Surgery)
Population: Intention-to-Treat (ITT) population; includes all patients who received the surgical intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baha Attract System | Time to Perform Surgery | 38.7 Minutes | Standard Deviation 10.7 |
Secondary
Tissue Reduction Performed During Surgery
Surgical thinning of the soft tissue flap was advocated when the soft tissue thickness exceeded 6 mm
Time frame: Visit 2 (surgery)
Population: Intention-to-Treat (ITT) population; all patients who received surgical intervention.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Baha Attract System | Tissue Reduction Performed During Surgery | Tissue thinning | 12 participants |
| Baha Attract System | Tissue Reduction Performed During Surgery | No tissue thinning | 42 participants |