Hearing Loss
Conditions
Keywords
Hearing Loss, Conductive, Hearing Loss, Mixed, Deafness, sensorineural single-sided
Brief summary
The aim of this clinical investigation is to collect data on objective and subjective hearing performance, quality of life and safety in adult subjects with conductive hearing loss, mixed hearing loss or single-sided sensorineural deafness.
Interventions
DEVICEOsia 2 system
System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor.
Sponsors
Statistiska Konsultgruppen
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
No
Inclusion criteria
* Subject with conductive hearing loss 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 sensorineural hearing loss. OR Subject with single-sided sensorineural deafness who is a candidate for Baha surgery. Air conduction thresholds with a pure tone average PTA4 (mean of 0.5, 1, 2 and 3 kHz) of ≤ 20 dB sensorineural hearing loss in the good ear OR subject who is indicated for an (Air Conduction-Contralateral Routing of Signal (AC CROS) but-for some reason-cannot or will not use an AC CROS. * Adult subjects (18 years or older). * Previous experience from amplified sound through properly fitted amplification (for example but not limited to Hearing aid, Contralateral Routing of Signal (CROS) device, Bone conduction hearing device on softband). * Candidate is a fluent speaker in the language used to assess speech perception performance. * Willing and able to provide written informed consent
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 to support successful implant placement. * Previous surgery and/or implantation with any bone conduction/active device on the side to be implanted, which may jeopardise the implantation and use of the Osia 2 system, as judged by the investigator. * 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, or unwilling to comply with the requirements of the clinical investigation as determined by the investigator. * Condition with a likely negative progression and/or with expected relapses jeopardising general wellbeing and health-related quality of life as judged by the investigator. * Subject that has received radiotherapy in the area of implantation or is planned for such radiotherapy during the study period. * Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling. * Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation * Currently participating, or participated within the last 30 days, in another interventional clinical investigation involving an investigational drug or device.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hearing Performance With the Osia 2 System at 3 Months Post-surgery Compared to Preoperative Unaided Condition Assessed Via Audiometric Thresholds | Baseline before surgery, 3 months after surgery | Free field (Pure Tone Average 4, mean of 0.5, 1,2 and 4 kHz) |
| Change in Hearing Performance With the Osia 2 System at 3 Months Post-surgery Compared to Preoperative Unaided Situation Assessed Via Adaptive Speech Recognition in Noise | Baseline before surgery, 3 months after surgery | Speech-to-noise ratio, 50% speech understanding |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds | Baseline before surgery, 4 weeks, 3 months and 6 months after surgery | Free-field \[0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz\] |
| Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Speech Recognition in Quiet | Baseline before surgery, 4 weeks, 3 months and 6 months after surgery | % correctly perceived words at 50dB, 65dB and 80dB SPL |
| Change in Self-reported Hearing Outcome With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire | Baseline before surgery, 3 months and 6 months after surgery | Measuring change of Ease of communication, Reverberation, Background noise, Aversiveness and a Global score with the Osia 2 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 impairment, a negative value an improvement. |
| Change in Self-reported Hearing Outcome With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Speech, Spatial and Qualities of Hearing Scale (SSQ) Questionnaire | Baseline before surgery, 3 months and 6 months after surgery | Measuring change of speech, spatial and hearing experiences with the Osia 2 System from the pe-operative unaided situation. A scale from 0 to 10 is used, 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. |
| Change in Health-related Quality of Life With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Health Utilities Index Mark III (HUI) Questionnaire | Baseline before surgery, 3 months and 6 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 Osia 2 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. |
| Surgical Information: Soft Tissue Thickness | Baseline before surgery or at surgery | Measured in mm |
| Surgical Information: Surgery Time | At surgery | Time in minutes between first incision to last suture |
| Surgical Information: Bone Polishing/Removal at the Actuator Site | At surgery | Yes/No |
| Surgical Information: BI300 Implant Length | At surgery | 3 mm/4 mm |
| Surgical Information: Location of BI300 Implant | At surgery | Measured in mm between the ear canal and the center of the actuator |
| Surgical Information: Type of Anesthesia | At surgery | General/local |
| Surgical Information: Soft Tissue Reduction | At surgery | Yes/No |
| Surgical Information: Surgical Incision Type | At surgery | Examples: C-shaped/S-shaped/straight |
| Change in Hearing Performance With the Osia 2 System at 4 Weeks and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds | Baseline before surgery, 4 weeks and 6 months after surgery | Free field (Pure Tone Average 4, mean of 0.5, 1,2 and 4 kHz) |
| Surgical Information: Estimated Length of the Surgical Incision | At surgery | Measured in mm |
| Surgical Information: Placement of the Coil | At surgery | Periosteal pocket (under periosteal)/on top of periosteum/on top of muscle) |
| Usability Information: Magnet Choice | At 4 weeks, 6 weeks, 3 months and 6 months after surgery | Magnet strength ranging from 1 to 4 where 1 is the weakest and 4 the strongest. A magnet allows the external sound processor to be placed in the correct position over the implanted system including an internal magnet. |
| Usability Information: Sound Processor Retention | At 4 weeks, 6 weeks, 3 months and 6 months after surgery | Assessed via a Visual Analog Scale 100 mm where 0 mm represents insufficient retention and 100 mm excellent retention |
| Usability Information: Sound Processor Wearing Comfort | At 4 weeks, 6 weeks, 3 months and 6 months after surgery | Assessed via a Visual Analog Scale 100 mm where 0 mm represents no comfort at all and 100 mm excellent comfort |
| Usability Information: Use of SoftWear Pad | At 6 weeks, 3 months and 6 months after surgery | Yes/No |
| Usability Information: Daily Use of Sound Processor | At 6 weeks, 3 months and 6 months after surgery | Average hours of daily use |
| Usability Information: Daily Streaming Time of Sound Processor | At 6 weeks, 3 months and 6 months after surgery | Average hours of daily streaming |
| Usability Information: Battery Lifetime of Sound Processor | At 6 weeks, 3 months and 6 months after surgery | Average hours of battery lifetime |
| Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds | Baseline before surgery, 4 weeks, 3 months and 6 months after surgery | Free-field \[Pure Tone Average (PTA) 4, Mean of 0.5, 1, 2 and 4 kHz\]. |
| Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Adaptive Speech Recognition in Noise | Baseline before surgery, 4 weeks, 3 months and 6 months after surgery | Signal-to-noise ratio, 50% speech understanding |
| Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Speech Recognition in Quiet | Baseline before surgery, 4 weeks, 3 months and 6 months after surgery | % correctly perceived words at 50dB, 65dB and 80dB SPL |
| Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct | Baseline before surgery, 4 weeks, 3 months and 6 months after surgery | BC direct (0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0 and 6.0 kHz) |
| Surgical Information: Location of the Surgical Incision in Relation to the Actuator | At surgery | Anterior/posterior |
| Change in Hearing Performance With the Osia 2 System at 4 Weeks and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Adaptive Speech Recognition in Noise | Baseline before surgery, 4 weeks and 6 months after surgery | Speech-to-noise ratio, 50% speech understanding |
Countries
Australia, Hong Kong
Participant flow
Recruitment details
29 participants were recruited in three centres from 16 August 2019 to 24 September 2020.
Participants by arm
| Arm | Count |
|---|---|
| Osia 2 System Osia 2 system: System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor. | 29 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Pregnancy | 1 |
| Overall Study | Unable to visit the site due to the Covid-19 travel restrictions | 1 |
Baseline characteristics
| Characteristic | Osia 2 System |
|---|---|
| Age, Continuous | 46.7 years STANDARD_DEVIATION 19.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 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 | 3 Participants |
| Race (NIH/OMB) White | 23 Participants |
| Region of Enrollment Australia | 26 participants |
| Region of Enrollment Hong Kong | 3 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 29 |
| other Total, other adverse events | 21 / 29 |
| serious Total, serious adverse events | 3 / 29 |
Outcome results
Primary
Change in Hearing Performance With the Osia 2 System at 3 Months Post-surgery Compared to Preoperative Unaided Condition Assessed Via Audiometric Thresholds
Free field (Pure Tone Average 4, mean of 0.5, 1,2 and 4 kHz)
Time frame: Baseline before surgery, 3 months after surgery
Population: Data was only received for 27 participants. One participant did not receive the sound processor due to the Covid-19 pandemic and one participant did not attend neither the 4 weeks visit nor the 3 months visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 3 Months Post-surgery Compared to Preoperative Unaided Condition Assessed Via Audiometric Thresholds | -27.3 db HL (decibel Hearing Level) | Standard Deviation 8.7 |
Primary
Change in Hearing Performance With the Osia 2 System at 3 Months Post-surgery Compared to Preoperative Unaided Situation Assessed Via Adaptive Speech Recognition in Noise
Speech-to-noise ratio, 50% speech understanding
Time frame: Baseline before surgery, 3 months after surgery
Population: Data was only received for 27 participants. One participant did not receive the sound processor due to the Covid-19 pandemic and one participant did not attend neither the 4 weeks visit nor the 3 months visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 3 Months Post-surgery Compared to Preoperative Unaided Situation Assessed Via Adaptive Speech Recognition in Noise | -9.10 db SNR (decibel Speech in Noise Ratio) | Standard Deviation 7.88 |
Secondary
Change in Health-related Quality of Life With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Health Utilities Index Mark III (HUI) Questionnaire
Change of health status and health related quality of life using the generic quality of life scale Health Utilities Index (HUI3) when wearing Osia 2 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.
Time frame: Baseline before surgery, 3 months and 6 months after surgery
Population: One participant did not receive the sound processor and did not perform this questionnaire at either 3- or 6-months visit.~One participant did not perform this questionnaire at 3-month visit and another participant did not perform this questionnaire at the 6-month visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Osia 2 System | Change in Health-related Quality of Life With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Health Utilities Index Mark III (HUI) Questionnaire | Comprehensive Health State, 3 months | 0.097 score on a scale | Standard Deviation 0.167 |
| Osia 2 System | Change in Health-related Quality of Life With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Health Utilities Index Mark III (HUI) Questionnaire | Vision attribute, 3 months | 0.002 score on a scale | Standard Deviation 0.017 |
| Osia 2 System | Change in Health-related Quality of Life With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Health Utilities Index Mark III (HUI) Questionnaire | Hearing attribute, 3 months | 0.113 score on a scale | Standard Deviation 0.288 |
| Osia 2 System | Change in Health-related Quality of Life With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Health Utilities Index Mark III (HUI) Questionnaire | Speech attribute, 3 months | 0.006 score on a scale | Standard Deviation 0.076 |
| Osia 2 System | Change in Health-related Quality of Life With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Health Utilities Index Mark III (HUI) Questionnaire | Ambulation attribute, 3 months | -0.006 score on a scale | Standard Deviation 0.033 |
| Osia 2 System | Change in Health-related Quality of Life With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Health Utilities Index Mark III (HUI) Questionnaire | Dexterity attribute, 3 months | 0.031 score on a scale | Standard Deviation 0.117 |
| Osia 2 System | Change in Health-related Quality of Life With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Health Utilities Index Mark III (HUI) Questionnaire | Emotion attribute, 3 months | 0.033 score on a scale | Standard Deviation 0.071 |
| Osia 2 System | Change in Health-related Quality of Life With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Health Utilities Index Mark III (HUI) Questionnaire | Cognition attribute, 3 months | 0.011 score on a scale | Standard Deviation 0.04 |
| Osia 2 System | Change in Health-related Quality of Life With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Health Utilities Index Mark III (HUI) Questionnaire | Pain attribute (HUI3), 3 months | 0.009 score on a scale | Standard Deviation 0.061 |
| Osia 2 System | Change in Health-related Quality of Life With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Health Utilities Index Mark III (HUI) Questionnaire | Comprehensive Health State, 6 months | 0.091 score on a scale | Standard Deviation 0.165 |
| Osia 2 System | Change in Health-related Quality of Life With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Health Utilities Index Mark III (HUI) Questionnaire | Vision attribute, 6 months | -0.004 score on a scale | Standard Deviation 0.013 |
| Osia 2 System | Change in Health-related Quality of Life With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Health Utilities Index Mark III (HUI) Questionnaire | Hearing attribute, 6 months | 0.129 score on a scale | Standard Deviation 0.318 |
| Osia 2 System | Change in Health-related Quality of Life With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Health Utilities Index Mark III (HUI) Questionnaire | Speech attribute, 6 months | 0.000 score on a scale | Standard Deviation 0.106 |
| Osia 2 System | Change in Health-related Quality of Life With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Health Utilities Index Mark III (HUI) Questionnaire | Ambulation attribute, 6 months | 0.013 score on a scale | Standard Deviation 0.045 |
| Osia 2 System | Change in Health-related Quality of Life With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Health Utilities Index Mark III (HUI) Questionnaire | Dexterity attribute, 6 months | 0.026 score on a scale | Standard Deviation 0.12 |
| Osia 2 System | Change in Health-related Quality of Life With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Health Utilities Index Mark III (HUI) Questionnaire | Emotion attribute, 6 months | 0.020 score on a scale | Standard Deviation 0.063 |
| Osia 2 System | Change in Health-related Quality of Life With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Health Utilities Index Mark III (HUI) Questionnaire | Cognition attribute, 6 months | 0.001 score on a scale | Standard Deviation 0.064 |
| Osia 2 System | Change in Health-related Quality of Life With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Health Utilities Index Mark III (HUI) Questionnaire | Pain attribute (HUI3), 6 months | 0.011 score on a scale | Standard Deviation 0.123 |
Secondary
Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds
Free-field \[0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz\]
Time frame: Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
Population: At the 4 weeks and 3 months visits, data was only received for 27 participants. One participant did not receive the sound processor due to the Covid-19 pandemic and one participant did not attend neither the 4 weeks visit nor the 3 months visit.~At the 6 months visit, data was received for 28 participants. The participant that did not attend previous visits did visit the site and data was collected. The participant that did not receive the sound processor still could not visit site.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds | 0.25 kHz, 4 weeks | -13.5 db HL (decibel Hearing Level) | Standard Deviation 12 |
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds | 0.5 kHz, 4 weeks | -23.1 db HL (decibel Hearing Level) | Standard Deviation 12.1 |
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds | 0.75 kHz, 4 weeks | -30.2 db HL (decibel Hearing Level) | Standard Deviation 10.6 |
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds | 1.0 kHz, 4 weeks | -28.3 db HL (decibel Hearing Level) | Standard Deviation 10.1 |
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds | 1.5 kHz, 4 weeks | -30.0 db HL (decibel Hearing Level) | Standard Deviation 10.7 |
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds | 2.0 kHz, 4 weeks | -25.7 db HL (decibel Hearing Level) | Standard Deviation 9.7 |
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds | 3.0 kHz, 4 weeks | -24.8 db HL (decibel Hearing Level) | Standard Deviation 11.6 |
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds | 4.0 kHz, 4 weeks | -25.4 db HL (decibel Hearing Level) | Standard Deviation 11.3 |
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds | 6.0 kHz, 4 weeks | -35.0 db HL (decibel Hearing Level) | Standard Deviation 11.9 |
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds | 8.0 kHz, 4 weeks | -5.44 db HL (decibel Hearing Level) | Standard Deviation 12.9 |
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds | 0.25 kHz, 3 months | -14.8 db HL (decibel Hearing Level) | Standard Deviation 11.1 |
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds | 0.5 kHz, 3 months | -24.4 db HL (decibel Hearing Level) | Standard Deviation 11.2 |
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds | 0.75 kHz, 3 months | -32.0 db HL (decibel Hearing Level) | Standard Deviation 10.8 |
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds | 1.0 kHz, 3 months | -29.1 db HL (decibel Hearing Level) | Standard Deviation 10.2 |
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds | 1.5 kHz, 3 months | -30.6 db HL (decibel Hearing Level) | Standard Deviation 11.3 |
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds | 2.0 kHz, 3 months | -27.0 db HL (decibel Hearing Level) | Standard Deviation 10.9 |
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds | 3.0 kHz, 3 months | -25.2 db HL (decibel Hearing Level) | Standard Deviation 11.5 |
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds | 4.0 kHz, 3 months | -28.7 db HL (decibel Hearing Level) | Standard Deviation 11.5 |
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds | 6.0 kHz, 3 months | -36.5 db HL (decibel Hearing Level) | Standard Deviation 12.1 |
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds | 8.0 kHz, 3 months | -8.59 db HL (decibel Hearing Level) | Standard Deviation 13.8 |
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds | 0.25 kHz, 6 months | -14.3 db HL (decibel Hearing Level) | Standard Deviation 12.8 |
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds | 0.5 kHz, 6 months | -24.6 db HL (decibel Hearing Level) | Standard Deviation 12.2 |
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds | 0.75 kHz, 6 months | -32.0 db HL (decibel Hearing Level) | Standard Deviation 11.5 |
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds | 1.0 kHz, 6 months | -31.3 db HL (decibel Hearing Level) | Standard Deviation 11.1 |
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds | 1.5 kHz, 6 months | -33.8 db HL (decibel Hearing Level) | Standard Deviation 10.9 |
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds | 2.0 kHz, 6 months | -28.4 db HL (decibel Hearing Level) | Standard Deviation 12.3 |
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds | 3.0 kHz, 6 months | -26.6 db HL (decibel Hearing Level) | Standard Deviation 9.9 |
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds | 4.0 kHz, 6 months | -29.3 db HL (decibel Hearing Level) | Standard Deviation 11.3 |
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds | 6.0 kHz, 6 months | -37.3 db HL (decibel Hearing Level) | Standard Deviation 12.5 |
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds | 8.0 kHz, 6 months | -7.71 db HL (decibel Hearing Level) | Standard Deviation 15.9 |
Secondary
Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Speech Recognition in Quiet
% correctly perceived words at 50dB, 65dB and 80dB SPL
Time frame: Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
Population: At the 4 weeks and 3 months visits, data was only received for 27 participants. One participant did not receive the sound processor due to the Covid-19 pandemic and one participant did not attend neither the 4 weeks visit nor the 3 months visit.~At the 6 months visit, data was received for 28 participants. The participant that did not attend previous visits did visit the site and data was collected. The participant that did not receive the sound processor still could not visit site.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Speech Recognition in Quiet | Speech in quiet at 50 dB, 4 weeks | 62.7 Percentage of correct words | Standard Deviation 20.7 |
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Speech Recognition in Quiet | Speech in quiet at 65 dB, 4 weeks | 55.1 Percentage of correct words | Standard Deviation 29.4 |
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Speech Recognition in Quiet | Speech in quiet at 80 dB, 4 weeks | 23.9 Percentage of correct words | Standard Deviation 27.5 |
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Speech Recognition in Quiet | Speech in quiet at 50 dB, 3 months | 63.8 Percentage of correct words | Standard Deviation 21.6 |
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Speech Recognition in Quiet | Speech in quiet at 65 dB, 3 months | 55.5 Percentage of correct words | Standard Deviation 29.3 |
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Speech Recognition in Quiet | Speech in quiet at 80 dB, 3 months | 23.7 Percentage of correct words | Standard Deviation 27.7 |
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Speech Recognition in Quiet | Speech in quiet at 50 dB, 6 months | 62.3 Percentage of correct words | Standard Deviation 22.1 |
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Speech Recognition in Quiet | Speech in quiet at 65 dB, 6 months | 54.0 Percentage of correct words | Standard Deviation 29.8 |
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Speech Recognition in Quiet | Speech in quiet at 80 dB, 6 months | 24.3 Percentage of correct words | Standard Deviation 28 |
Secondary
Change in Hearing Performance With the Osia 2 System at 4 Weeks and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Adaptive Speech Recognition in Noise
Speech-to-noise ratio, 50% speech understanding
Time frame: Baseline before surgery, 4 weeks and 6 months after surgery
Population: At 4 weeks, data was only received for 27 participants. One participant did not receive the sound processor due to the Covid-19 pandemic and one participant did not attend neither the 4 weeks visit nor the 3 months visit.~At 6 months visit, data was received for 28 participants.The participant that did not attend previous visits did visit the site and data was collected. The participant that did not receive the sound processor still could not visit site.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 4 Weeks and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Adaptive Speech Recognition in Noise | 4 weeks | -8.76 db SNR (decibel Speech in Noise Ratio) | Standard Deviation 8.06 |
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 4 Weeks and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Adaptive Speech Recognition in Noise | 6 months | -8.84 db SNR (decibel Speech in Noise Ratio) | Standard Deviation 7.88 |
Secondary
Change in Hearing Performance With the Osia 2 System at 4 Weeks and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds
Free field (Pure Tone Average 4, mean of 0.5, 1,2 and 4 kHz)
Time frame: Baseline before surgery, 4 weeks and 6 months after surgery
Population: At 4 weeks, data was only received for 27 participants. One participant did not receive the sound processor due to the Covid-19 pandemic and one participant did not attend neither the 4 weeks visit nor the 3 months visit.~At 6 months visit, data was received for 28 participants.The participant that did not attend previous visits did visit the site and data was collected. The participant that did not receive the sound processor still could not visit site.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 4 Weeks and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds | 4 weeks | -25.6 db HL (decibel Hearing Level) | Standard Deviation 8.3 |
| Osia 2 System | Change in Hearing Performance With the Osia 2 System at 4 Weeks and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds | 6 months | -28.4 db HL (decibel Hearing Level) | Standard Deviation 9.6 |
Secondary
Change in Self-reported Hearing Outcome With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire
Measuring change of Ease of communication, Reverberation, Background noise, Aversiveness and a Global score with the Osia 2 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 impairment, a negative value an improvement.
Time frame: Baseline before surgery, 3 months and 6 months after surgery
Population: One participant did not receive the sound processor and did not perform this questionnaire at either 3- or 6-months visit.~One participant did not perform this questionnaire at 3-month visit and another participant did not perform this questionnaire at the 6-month visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Osia 2 System | Change in Self-reported Hearing Outcome With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire | APHAB - Ease of communication, 3 months | 28.1 units on a scale | Standard Deviation 30.7 |
| Osia 2 System | Change in Self-reported Hearing Outcome With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire | APHAB - Background Noise, 3 months | 27.6 units on a scale | Standard Deviation 26.9 |
| Osia 2 System | Change in Self-reported Hearing Outcome With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire | APHAB - Reverberation, 3 months | 20.3 units on a scale | Standard Deviation 24.3 |
| Osia 2 System | Change in Self-reported Hearing Outcome With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire | APHAB - Aversiveness, 3 months | -5.2 units on a scale | Standard Deviation 34.9 |
| Osia 2 System | Change in Self-reported Hearing Outcome With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire | APHAB - Global, 3 months | 25.4 units on a scale | Standard Deviation 25 |
| Osia 2 System | Change in Self-reported Hearing Outcome With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire | APHAB - Ease of communication, 6 months | 27.4 units on a scale | Standard Deviation 31.4 |
| Osia 2 System | Change in Self-reported Hearing Outcome With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire | APHAB - Background Noise, 6 months | 28.7 units on a scale | Standard Deviation 28.1 |
| Osia 2 System | Change in Self-reported Hearing Outcome With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire | APHAB - Reverberation, 6 months | 21.7 units on a scale | Standard Deviation 26.4 |
| Osia 2 System | Change in Self-reported Hearing Outcome With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire | APHAB - Aversiveness, 6 months | -0.212 units on a scale | Standard Deviation 33 |
| Osia 2 System | Change in Self-reported Hearing Outcome With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire | APHAB - Global, 6 months | 25.9 units on a scale | Standard Deviation 26.2 |
Secondary
Change in Self-reported Hearing Outcome With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Speech, Spatial and Qualities of Hearing Scale (SSQ) Questionnaire
Measuring change of speech, spatial and hearing experiences with the Osia 2 System from the pe-operative unaided situation. A scale from 0 to 10 is used, 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, 3 months and 6 months after surgery
Population: One participant did not receive the sound processor and did not perform this questionnaire at either 3- or 6-months visit.~One participant did not perform this questionnaire at 3-month visit and another participant did not perform this questionnaire at the 6-month visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Osia 2 System | Change in Self-reported Hearing Outcome With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Speech, Spatial and Qualities of Hearing Scale (SSQ) Questionnaire | SSQ12 Total score, 3 months | 2.88 Score on a scale | Standard Deviation 1.56 |
| Osia 2 System | Change in Self-reported Hearing Outcome With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Speech, Spatial and Qualities of Hearing Scale (SSQ) Questionnaire | SSQ12 Speech score, 3 months | 3.12 Score on a scale | Standard Deviation 1.78 |
| Osia 2 System | Change in Self-reported Hearing Outcome With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Speech, Spatial and Qualities of Hearing Scale (SSQ) Questionnaire | SSQ12 Spatial score, 3 months | 2.92 Score on a scale | Standard Deviation 2.07 |
| Osia 2 System | Change in Self-reported Hearing Outcome With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Speech, Spatial and Qualities of Hearing Scale (SSQ) Questionnaire | SSQ12 Quality score, 3 months | 2.55 Score on a scale | Standard Deviation 1.78 |
| Osia 2 System | Change in Self-reported Hearing Outcome With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Speech, Spatial and Qualities of Hearing Scale (SSQ) Questionnaire | SSQ12 Total score, 6 months | 2.50 Score on a scale | Standard Deviation 1.66 |
| Osia 2 System | Change in Self-reported Hearing Outcome With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Speech, Spatial and Qualities of Hearing Scale (SSQ) Questionnaire | SSQ12 Speech score, 6 months | 2.68 Score on a scale | Standard Deviation 1.89 |
| Osia 2 System | Change in Self-reported Hearing Outcome With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Speech, Spatial and Qualities of Hearing Scale (SSQ) Questionnaire | SSQ12 Spatial score, 6 months | 2.30 Score on a scale | Standard Deviation 2.42 |
| Osia 2 System | Change in Self-reported Hearing Outcome With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Speech, Spatial and Qualities of Hearing Scale (SSQ) Questionnaire | SSQ12 Quality score, 6 months | 2.41 Score on a scale | Standard Deviation 1.81 |
Secondary
Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Adaptive Speech Recognition in Noise
Signal-to-noise ratio, 50% speech understanding
Time frame: Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
Population: Some participants did not perform the test at all visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Adaptive Speech Recognition in Noise | 4 weeks | -0.870 db SNR (decibel Speech in Noise Ratio) | Standard Deviation 1.366 |
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Adaptive Speech Recognition in Noise | 3 months | -1.21 db SNR (decibel Speech in Noise Ratio) | Standard Deviation 1.42 |
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Adaptive Speech Recognition in Noise | 6 months | -0.846 db SNR (decibel Speech in Noise Ratio) | Standard Deviation 1.587 |
Secondary
Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds
Free-field \[Pure Tone Average (PTA) 4, Mean of 0.5, 1, 2 and 4 kHz\].
Time frame: Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
Population: Some participants did not perform the test at all visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds | PTA4, 4 weeks | 0.046 db HL (decibel Hearing Level) | Standard Deviation 7.134 |
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds | PTA4, 3 months | -1.62 db HL (decibel Hearing Level) | Standard Deviation 6.41 |
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds | PTA4, 6 months | -2.54 db HL (decibel Hearing Level) | Standard Deviation 8.32 |
Secondary
Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds
Free-field \[0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz\].
Time frame: Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
Population: Some participants did not perform the test at all visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds | 0.25 kHz, 4 weeks | 4.44 db HL (decibel Hearing Level) | Standard Deviation 13.18 |
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds | 0.5 kHz, 4 weeks | 4.44 db HL (decibel Hearing Level) | Standard Deviation 10.13 |
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds | 0.75 kHz, 4 weeks | -0.741 db HL (decibel Hearing Level) | Standard Deviation 6.893 |
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds | 1.0 kHz, 4 weeks | 1.85 db HL (decibel Hearing Level) | Standard Deviation 7.61 |
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds | 1.5 kHz, 4 weeks | 0.185 db HL (decibel Hearing Level) | Standard Deviation 8.376 |
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds | 2.0 kHz, 4 weeks | -2.22 db HL (decibel Hearing Level) | Standard Deviation 8.7 |
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds | 3.0 kHz, 4 weeks | -1.48 db HL (decibel Hearing Level) | Standard Deviation 10.27 |
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds | 4.0 kHz, 4 weeks | -3.89 db HL (decibel Hearing Level) | Standard Deviation 11.21 |
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds | 6.0 kHz, 4 weeks | -11.9 db HL (decibel Hearing Level) | Standard Deviation 10.9 |
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds | 8.0 kHz, 4 weeks | 4.78 db HL (decibel Hearing Level) | Standard Deviation 16.49 |
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds | 0.25 kHz, 3 months | 3.15 db HL (decibel Hearing Level) | Standard Deviation 10.57 |
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds | 0.5 kHz, 3 months | 3.15 db HL (decibel Hearing Level) | Standard Deviation 9.11 |
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds | 0.75 kHz, 3 months | -2.59 db HL (decibel Hearing Level) | Standard Deviation 6.7 |
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds | 1.0 kHz, 3 months | 1.11 db HL (decibel Hearing Level) | Standard Deviation 6.55 |
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds | 1.5 kHz, 3 months | -0,370 db HL (decibel Hearing Level) | — |
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds | 2.0 kHz, 3 months | -3.52 db HL (decibel Hearing Level) | Standard Deviation 8.64 |
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds | 3.0 kHz, 3 months | -1.85 db HL (decibel Hearing Level) | Standard Deviation 10.48 |
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds | 4.0 kHz, 3 months | -7.22 db HL (decibel Hearing Level) | Standard Deviation 10.41 |
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds | 6.0 kHz, 3 months | -13.3 db HL (decibel Hearing Level) | Standard Deviation 10.3 |
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds | 8.0 kHz, 3 months | 1.63 db HL (decibel Hearing Level) | Standard Deviation 15.2 |
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds | 0.25 kHz, 6 months | 3.93 db HL (decibel Hearing Level) | Standard Deviation 13.77 |
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds | 0.5 kHz, 6 months | 2.86 db HL (decibel Hearing Level) | Standard Deviation 9.95 |
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds | 0.75 kHz, 6 months | -2.68 db HL (decibel Hearing Level) | Standard Deviation 8.76 |
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds | 1.0 kHz, 6 months | -1.07 db HL (decibel Hearing Level) | Standard Deviation 7.98 |
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds | 1.5 kHz, 6 months | -3.39 db HL (decibel Hearing Level) | Standard Deviation 7.34 |
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds | 2.0 kHz, 6 months | -4.64 db HL (decibel Hearing Level) | Standard Deviation 10.97 |
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds | 3.0 kHz, 6 months | -3.04 db HL (decibel Hearing Level) | Standard Deviation 12.35 |
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds | 4.0 kHz, 6 months | -7.32 db HL (decibel Hearing Level) | Standard Deviation 11.26 |
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds | 6.0 kHz, 6 months | -13.9 db HL (decibel Hearing Level) | Standard Deviation 13.6 |
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds | 8.0 kHz, 6 months | 2.86 db HL (decibel Hearing Level) | Standard Deviation 17.87 |
Secondary
Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Speech Recognition in Quiet
% correctly perceived words at 50dB, 65dB and 80dB SPL
Time frame: Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
Population: Some participants did not perform all tests at all visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Speech Recognition in Quiet | Speech in quiet at 50 dB, 4 weeks | 12.2 Percentage of correct words | Standard Deviation 18.3 |
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Speech Recognition in Quiet | Speech in quiet at 65 dB, 4 weeks | 9.77 Percentage of correct words | Standard Deviation 14.76 |
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Speech Recognition in Quiet | Speech in quiet at 80 dB, 4 weeks | 2.88 Percentage of correct words | Standard Deviation 10.21 |
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Speech Recognition in Quiet | Speech in quiet at 50 dB, 3 months | 13.2 Percentage of correct words | Standard Deviation 18.8 |
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Speech Recognition in Quiet | Speech in quiet at 65 dB, 3 months | 10.1 Percentage of correct words | Standard Deviation 16 |
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Speech Recognition in Quiet | Speech in quiet at 80 dB, 3 months | 2.66 Percentage of correct words | Standard Deviation 10.13 |
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Speech Recognition in Quiet | Speech in quiet at 50 dB, 6 months | 10.7 Percentage of correct words | Standard Deviation 18.3 |
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Speech Recognition in Quiet | Speech in quiet at 65 dB, 6 months | 8.84 Percentage of correct words | Standard Deviation 15.22 |
| Osia 2 System | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Speech Recognition in Quiet | Speech in quiet at 80 dB, 6 months | 4.00 Percentage of correct words | Standard Deviation 8.26 |
Secondary
Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct
BC direct (0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0 and 6.0 kHz)
Time frame: Baseline before surgery, 4 weeks, 3 months and 6 months after surgery
Population: Some participants did not perform the test at all visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Osia 2 System | Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct | BC Direct 250 Hz, baseline | 13.2 db HL (decibel Hearing Level) | Standard Deviation 10.2 |
| Osia 2 System | Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct | BC Direct 500 Hz, baseline | 24.7 db HL (decibel Hearing Level) | Standard Deviation 11.3 |
| Osia 2 System | Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct | BC Direct 750 Hz, baseline | 20.7 db HL (decibel Hearing Level) | Standard Deviation 12.4 |
| Osia 2 System | Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct | BC Direct 1000 Hz, baseline | 20.0 db HL (decibel Hearing Level) | Standard Deviation 13.5 |
| Osia 2 System | Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct | BC Direct 1500 Hz, baseline | 19.1 db HL (decibel Hearing Level) | Standard Deviation 14.6 |
| Osia 2 System | Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct | BC Direct 2000 Hz, baseline | 31.2 db HL (decibel Hearing Level) | Standard Deviation 15.3 |
| Osia 2 System | Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct | BC Direct 3000 Hz, baseline | 36.8 db HL (decibel Hearing Level) | Standard Deviation 18.7 |
| Osia 2 System | Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct | BC Direct 4000 Hz, baseline | 43.5 db HL (decibel Hearing Level) | Standard Deviation 17.6 |
| Osia 2 System | Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct | BC Direct 6000 Hz, baseline | 46.1 db HL (decibel Hearing Level) | Standard Deviation 17.6 |
| Osia 2 System | Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct | BC Direct 250 Hz, 4 weeks | 5.18 db HL (decibel Hearing Level) | Standard Deviation 12.87 |
| Osia 2 System | Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct | BC Direct 500 Hz, 4 weeks | 14.5 db HL (decibel Hearing Level) | Standard Deviation 8.7 |
| Osia 2 System | Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct | BC Direct 750 Hz, 4 weeks | 5.71 db HL (decibel Hearing Level) | Standard Deviation 11.2 |
| Osia 2 System | Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct | BC Direct 1000 Hz, 4 weeks | 9.46 db HL (decibel Hearing Level) | Standard Deviation 11.33 |
| Osia 2 System | Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct | BC Direct 1500 Hz, 4 weeks | 7.50 db HL (decibel Hearing Level) | Standard Deviation 13.23 |
| Osia 2 System | Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct | BC Direct 2000 Hz, 4 weeks | 12.0 db HL (decibel Hearing Level) | Standard Deviation 14.2 |
| Osia 2 System | Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct | BC Direct 3000 Hz, 4 weeks | 13.9 db HL (decibel Hearing Level) | Standard Deviation 15.4 |
| Osia 2 System | Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct | BC Direct 4000 Hz, 4 weeks | 23.8 db HL (decibel Hearing Level) | Standard Deviation 17.1 |
| Osia 2 System | Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct | BC Direct 6000 Hz, 4 weeks | 22.0 db HL (decibel Hearing Level) | Standard Deviation 18.7 |
| Osia 2 System | Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct | BC Direct 250 Hz, 3 months | 4.00 db HL (decibel Hearing Level) | Standard Deviation 11.21 |
| Osia 2 System | Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct | BC Direct 500 Hz, 3 months | 13.0 db HL (decibel Hearing Level) | Standard Deviation 9.8 |
| Osia 2 System | Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct | BC Direct 750 Hz, 3 months | 4.33 db HL (decibel Hearing Level) | Standard Deviation 12.08 |
| Osia 2 System | Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct | BC Direct 1000 Hz, 3 months | 9.67 db HL (decibel Hearing Level) | Standard Deviation 13.29 |
| Osia 2 System | Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct | BC Direct 1500 Hz, 3 months | 6.67 db HL (decibel Hearing Level) | Standard Deviation 15.43 |
| Osia 2 System | Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct | BC Direct 2000 Hz, 3 months | 14.0 db HL (decibel Hearing Level) | Standard Deviation 15.9 |
| Osia 2 System | Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct | BC Direct 3000 Hz, 3 months | 13.3 db HL (decibel Hearing Level) | Standard Deviation 18.5 |
| Osia 2 System | Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct | BC Direct 4000 Hz, 3 months | 24.3 db HL (decibel Hearing Level) | Standard Deviation 17.4 |
| Osia 2 System | Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct | BC Direct 6000 Hz, 3 months | 27.0 db HL (decibel Hearing Level) | Standard Deviation 18.5 |
| Osia 2 System | Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct | BC Direct 250 Hz, 6 months | 8.10 db HL (decibel Hearing Level) | Standard Deviation 13.83 |
| Osia 2 System | Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct | BC Direct 500 Hz, 6 months | 15.0 db HL (decibel Hearing Level) | Standard Deviation 8.5 |
| Osia 2 System | Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct | BC Direct 750 Hz, 6 months | 6.90 db HL (decibel Hearing Level) | Standard Deviation 12.6 |
| Osia 2 System | Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct | BC Direct 1000 Hz, 6 months | 10.7 db HL (decibel Hearing Level) | Standard Deviation 11.3 |
| Osia 2 System | Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct | BC Direct 1500 Hz, 6 months | 5.95 db HL (decibel Hearing Level) | Standard Deviation 13.84 |
| Osia 2 System | Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct | BC Direct 2000 Hz, 6 months | 14.3 db HL (decibel Hearing Level) | Standard Deviation 13.7 |
| Osia 2 System | Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct | BC Direct 3000 Hz, 6 months | 13.6 db HL (decibel Hearing Level) | Standard Deviation 17 |
| Osia 2 System | Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct | BC Direct 4000 Hz, 6 months | 25.7 db HL (decibel Hearing Level) | Standard Deviation 16.9 |
| Osia 2 System | Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct | BC Direct 6000 Hz, 6 months | 25.0 db HL (decibel Hearing Level) | Standard Deviation 18.8 |
Secondary
Surgical Information: BI300 Implant Length
3 mm/4 mm
Time frame: At surgery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Osia 2 System | Surgical Information: BI300 Implant Length | 4 mm | 29 Participants |
| Osia 2 System | Surgical Information: BI300 Implant Length | 3 mm | 0 Participants |
Secondary
Surgical Information: Bone Polishing/Removal at the Actuator Site
Yes/No
Time frame: At surgery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Osia 2 System | Surgical Information: Bone Polishing/Removal at the Actuator Site | Yes | 12 Participants |
| Osia 2 System | Surgical Information: Bone Polishing/Removal at the Actuator Site | No | 17 Participants |
Secondary
Surgical Information: Estimated Length of the Surgical Incision
Measured in mm
Time frame: At surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Osia 2 System | Surgical Information: Estimated Length of the Surgical Incision | 71.4 mm | Standard Deviation 23.1 |
Secondary
Surgical Information: Location of BI300 Implant
Measured in mm between the ear canal and the center of the actuator
Time frame: At surgery
Population: Data only gathered for 26 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Osia 2 System | Surgical Information: Location of BI300 Implant | 52.9 mm | Standard Deviation 7.3 |
Secondary
Surgical Information: Location of the Surgical Incision in Relation to the Actuator
Anterior/posterior
Time frame: At surgery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Osia 2 System | Surgical Information: Location of the Surgical Incision in Relation to the Actuator | Anterior | 26 Participants |
| Osia 2 System | Surgical Information: Location of the Surgical Incision in Relation to the Actuator | Posterior | 3 Participants |
Secondary
Surgical Information: Placement of the Coil
Periosteal pocket (under periosteal)/on top of periosteum/on top of muscle)
Time frame: At surgery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Osia 2 System | Surgical Information: Placement of the Coil | Periosteal pocket (under periosteal) | 24 Participants |
| Osia 2 System | Surgical Information: Placement of the Coil | on top of periosteum | 3 Participants |
| Osia 2 System | Surgical Information: Placement of the Coil | on top of muscle | 2 Participants |
Secondary
Surgical Information: Soft Tissue Reduction
Yes/No
Time frame: At surgery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Osia 2 System | Surgical Information: Soft Tissue Reduction | Yes | 0 Participants |
| Osia 2 System | Surgical Information: Soft Tissue Reduction | No | 29 Participants |
Secondary
Surgical Information: Soft Tissue Thickness
Measured in mm
Time frame: Baseline before surgery or at surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Osia 2 System | Surgical Information: Soft Tissue Thickness | 6.62 mm | Standard Deviation 1.29 |
Secondary
Surgical Information: Surgery Time
Time in minutes between first incision to last suture
Time frame: At surgery
Population: Surgery time was not measured for one of the participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Osia 2 System | Surgical Information: Surgery Time | 52.8 min | Standard Deviation 13.3 |
Secondary
Surgical Information: Surgical Incision Type
Examples: C-shaped/S-shaped/straight
Time frame: At surgery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Osia 2 System | Surgical Information: Surgical Incision Type | C-shaped | 12 Participants |
| Osia 2 System | Surgical Information: Surgical Incision Type | S-shaped | 12 Participants |
| Osia 2 System | Surgical Information: Surgical Incision Type | Other | 5 Participants |
| Osia 2 System | Surgical Information: Surgical Incision Type | Straight | 0 Participants |
Secondary
Surgical Information: Type of Anesthesia
General/local
Time frame: At surgery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Osia 2 System | Surgical Information: Type of Anesthesia | General | 29 Participants |
| Osia 2 System | Surgical Information: Type of Anesthesia | Local | 0 Participants |
Secondary
Usability Information: Battery Lifetime of Sound Processor
Average hours of battery lifetime
Time frame: At 6 weeks, 3 months and 6 months after surgery
Population: For some participants the data are not available at all visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Osia 2 System | Usability Information: Battery Lifetime of Sound Processor | 6 weeks | 27.3 hours | Standard Deviation 15 |
| Osia 2 System | Usability Information: Battery Lifetime of Sound Processor | 3 months | 27.4 hours | Standard Deviation 11.2 |
| Osia 2 System | Usability Information: Battery Lifetime of Sound Processor | 6 months | 24.3 hours | Standard Deviation 12.4 |
Secondary
Usability Information: Daily Streaming Time of Sound Processor
Average hours of daily streaming
Time frame: At 6 weeks, 3 months and 6 months after surgery
Population: For some participants the data are not available at all visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Osia 2 System | Usability Information: Daily Streaming Time of Sound Processor | Streaming, 6 weeks | 0.407 hours/day | Standard Deviation 0.931 |
| Osia 2 System | Usability Information: Daily Streaming Time of Sound Processor | Streaming, 3 months | 0.536 hours/day | Standard Deviation 0.962 |
| Osia 2 System | Usability Information: Daily Streaming Time of Sound Processor | Streaming, 6 months | 0.444 hours/day | Standard Deviation 0.698 |
Secondary
Usability Information: Daily Use of Sound Processor
Average hours of daily use
Time frame: At 6 weeks, 3 months and 6 months after surgery
Population: For some participants the data are not available at all visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Osia 2 System | Usability Information: Daily Use of Sound Processor | Daily use, 6 weeks | 10.3 hours/day | Standard Deviation 4.4 |
| Osia 2 System | Usability Information: Daily Use of Sound Processor | Daily use, 3 months | 9.57 hours/day | Standard Deviation 4.19 |
| Osia 2 System | Usability Information: Daily Use of Sound Processor | Daily use, 6 months | 8.63 hours/day | Standard Deviation 4.67 |
Secondary
Usability Information: Magnet Choice
Magnet strength ranging from 1 to 4 where 1 is the weakest and 4 the strongest. A magnet allows the external sound processor to be placed in the correct position over the implanted system including an internal magnet.
Time frame: At 4 weeks, 6 weeks, 3 months and 6 months after surgery
Population: For some participants the data are not available at all visits.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Osia 2 System | Usability Information: Magnet Choice | Magnet strength 2, 4 weeks | 1 Participants |
| Osia 2 System | Usability Information: Magnet Choice | Magnet strength 3, 4 weeks | 11 Participants |
| Osia 2 System | Usability Information: Magnet Choice | Magnet strength 4, 4 weeks | 16 Participants |
| Osia 2 System | Usability Information: Magnet Choice | Magnet strength 2, 6 weeks | 1 Participants |
| Osia 2 System | Usability Information: Magnet Choice | Magnet strength 3, 6 weeks | 13 Participants |
| Osia 2 System | Usability Information: Magnet Choice | Magnet strength 4, 6 weeks | 13 Participants |
| Osia 2 System | Usability Information: Magnet Choice | Magnet strength 2, 3 months | 4 Participants |
| Osia 2 System | Usability Information: Magnet Choice | Magnet strength 3, 3 months | 10 Participants |
| Osia 2 System | Usability Information: Magnet Choice | Magnet strength 4, 3 months | 14 Participants |
| Osia 2 System | Usability Information: Magnet Choice | Magnet strength 2, 6 months | 4 Participants |
| Osia 2 System | Usability Information: Magnet Choice | Magnet strength 3, 6 months | 12 Participants |
| Osia 2 System | Usability Information: Magnet Choice | Magnet strength 4, 6 months | 11 Participants |
Secondary
Usability Information: Sound Processor Retention
Assessed via a Visual Analog Scale 100 mm where 0 mm represents insufficient retention and 100 mm excellent retention
Time frame: At 4 weeks, 6 weeks, 3 months and 6 months after surgery
Population: Some participants did not perform the test at all visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Osia 2 System | Usability Information: Sound Processor Retention | Overall Retention, 4 weeks | 72.1 units on a scale | Standard Deviation 22.8 |
| Osia 2 System | Usability Information: Sound Processor Retention | Overall Retention, 6 weeks | 86.9 units on a scale | Standard Deviation 13.9 |
| Osia 2 System | Usability Information: Sound Processor Retention | Overall Retention, 3 months | 80.4 units on a scale | Standard Deviation 17.1 |
| Osia 2 System | Usability Information: Sound Processor Retention | Overall Retention, 6 months | 71.4 units on a scale | Standard Deviation 26.7 |
Secondary
Usability Information: Sound Processor Wearing Comfort
Assessed via a Visual Analog Scale 100 mm where 0 mm represents no comfort at all and 100 mm excellent comfort
Time frame: At 4 weeks, 6 weeks, 3 months and 6 months after surgery
Population: Some participants did not perform the test at all visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Osia 2 System | Usability Information: Sound Processor Wearing Comfort | Overall Comfort, 4 weeks | 81.7 units on a scale | Standard Deviation 14.1 |
| Osia 2 System | Usability Information: Sound Processor Wearing Comfort | Overall Comfort, 6 weeks | 87.1 units on a scale | Standard Deviation 16.8 |
| Osia 2 System | Usability Information: Sound Processor Wearing Comfort | Overall Comfort, 3 months | 83.5 units on a scale | Standard Deviation 16.4 |
| Osia 2 System | Usability Information: Sound Processor Wearing Comfort | Overall Comfort, 6 months | 81.4 units on a scale | Standard Deviation 20 |
Secondary
Usability Information: Use of SoftWear Pad
Yes/No
Time frame: At 6 weeks, 3 months and 6 months after surgery
Population: For some participants the data are not available at all visits.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Osia 2 System | Usability Information: Use of SoftWear Pad | Yes, 6 weeks | 3 Participants |
| Osia 2 System | Usability Information: Use of SoftWear Pad | No, 6 weeks | 24 Participants |
| Osia 2 System | Usability Information: Use of SoftWear Pad | Yes, 3 months | 4 Participants |
| Osia 2 System | Usability Information: Use of SoftWear Pad | No, 3 months | 24 Participants |
| Osia 2 System | Usability Information: Use of SoftWear Pad | Yes, 6 months | 2 Participants |
| Osia 2 System | Usability Information: Use of SoftWear Pad | No, 6 months | 25 Participants |