N/A
N=29
Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System
Hearing Loss
Bottom Line
View on ClinicalTrials.gov: NCT04041700 ↗Enrolled (actual)
29
Serious AEs
10.3%
Results posted
Aug 2021
Primary outcome: Primary: 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)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Osia 2 system (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cochlear
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 | — |
| 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 |
-9.10 | — |
| 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 |
-25.6; -28.4 | — |
| 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 |
-8.76; -8.84 | — |
| 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 |
-13.5; -23.1; -30.2; -28.3; -30.0; -25.7 | — |
| 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 |
62.7; 55.1; 23.9; 63.8; 55.5; 23.7 | — |
| 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 |
28.1; 27.6; 20.3; -5.2; 25.4; 27.4 | — |
| 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 |
2.88; 3.12; 2.92; 2.55; 2.50; 2.68 | — |
| 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 |
0.097; 0.002; 0.113; 0.006; -0.006; 0.031 | — |
| SECONDARY Surgical Information: Soft Tissue Thickness |
6.62 | — |
| SECONDARY Surgical Information: Surgery Time |
52.8 | — |
| SECONDARY Surgical Information: Bone Polishing/Removal at the Actuator Site |
12; 17 | — |
| SECONDARY Surgical Information: BI300 Implant Length |
0; 29 | — |
| SECONDARY Surgical Information: Location of BI300 Implant |
52.9 | — |
| SECONDARY Surgical Information: Type of Anesthesia |
29; 0 | — |
| SECONDARY Surgical Information: Soft Tissue Reduction |
0; 29 | — |
| SECONDARY Surgical Information: Surgical Incision Type |
12; 12; 5; 0 | — |
| SECONDARY Surgical Information: Location of the Surgical Incision in Relation to the Actuator |
26; 3 | — |
| SECONDARY Surgical Information: Estimated Length of the Surgical Incision |
71.4 | — |
| SECONDARY Surgical Information: Placement of the Coil |
24; 3; 2 | — |
| SECONDARY Usability Information: Magnet Choice |
1; 11; 16; 1; 13; 13 | — |
| SECONDARY Usability Information: Sound Processor Retention |
72.1; 86.9; 80.4; 71.4 | — |
| SECONDARY Usability Information: Sound Processor Wearing Comfort |
81.7; 87.1; 83.5; 81.4 | — |
| SECONDARY Usability Information: Use of SoftWear Pad |
3; 24; 4; 24; 2; 25 | — |
| SECONDARY Usability Information: Daily Use of Sound Processor |
10.3; 9.57; 8.63 | — |
| SECONDARY Usability Information: Daily Streaming Time of Sound Processor |
0.407; 0.536; 0.444 | — |
| SECONDARY Usability Information: Battery Lifetime of Sound Processor |
27.3; 27.4; 24.3 | — |
| 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 |
4.44; 4.44; -0.741; 1.85; 0.185; -2.22 | — |
| 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 |
4.44; 4.44; -0.741; 1.85; 0.185; -2.22 | — |
| 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 |
-0.870; -1.21; -0.846 | — |
| 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 |
12.2; 9.77; 2.88; 13.2; 10.1; 2.66 | — |
| 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 |
13.2; 24.7; 20.7; 20.0; 19.1; 31.2 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04041700). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.