An interventional study of Osia 2 System in Conductive Hearing Loss and Mixed Hearing Loss, sponsored by Cochlear. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-25.
Sponsored by Cochlear · Not applicable, Interventional, and Treatment
To evaluate the clinical efficacy of the Osia 2 system in patients with conductive or mixed conductive hearing loss in a US cohort.
1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.
This study's enrollment of 20 is below the median of 40 across 764 interventional studies indexed under Hearing Loss.
Browse Hearing Loss studies →Cochlear is the lead sponsor of 91 studies on the registry; 11 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 15 (94%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Osia 2 Active Osseointegrated Implant System for Bone Conduction
Device: Osia 2 System
The external Sound Processor, Osia 2 Active Osseointegrated Implant System for Bone Conduction, captures and digitizes the sound which is transferred to the internal implant where it is converted to an electrical signal.
Change From Baseline in Adaptive Speech in Noise Test Score for Osia 2 System at 3 Months Post-surgery
Assessed with the Quick SIN test preoperative and at 3 months post-surgery. The Quick SIN test has a score range from +25.5 dB (decibel) SNR (signal-to-noise ratio) to -5 dB SNR. The participants are tested on 4 tests lists; each consists of 6 sentences (with 5 key words per sentence) that are presented at signal-to-noise ratios (SNR) which are decreased manually in 5-dB steps from 25 to 0. The key words in sentences are scored and counted as correct from an easy to difficult or unfavorable SNR. The best possible score on this test would be that of -5 dB SNR where all of the key words are repeated back correctly as a function of the SNR. The mean unaided preoperative score is substracted from the aided score at 3 months. A lower score indicates a better performance.
Time frame: Preoperative, 3 months post-surgery
Number of Device or Procedure Related Adverse Events
A device or procedure related adverse event (AE) is an AE for which a causal relationship between the use of the medical device and the AE cannot be ruled out. All related AEs are reported.
Time frame: 6 months post-surgery
| Milestone | Osia 2 System |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
Assessed with the Quick SIN test preoperative and at 3 months post-surgery. The Quick SIN test has a score range from +25.5 dB (decibel) SNR (signal-to-noise ratio) to -5 dB SNR. The participants are tested on 4 tests lists; each consists of 6 sentences (with 5 key words per sentence) that are presented at signal-to-noise ratios (SNR) which are decreased manually in 5-dB steps from 25 to 0. The key words in sentences are scored and counted as correct from an easy to difficult or unfavorable SNR. The best possible score on this test would be that of -5 dB SNR where all of the key words are repeated back correctly as a function of the SNR. The mean unaided preoperative score is substracted from the aided score at 3 months. A lower score indicates a better performance.
| Score on a scale | Osia 2 System |
|---|---|
| Change From Baseline in Adaptive Speech in Noise Test Score for Osia 2 System at 3 Months Post-surgery | 6.1 ± 6.9 |
A device or procedure related adverse event (AE) is an AE for which a causal relationship between the use of the medical device and the AE cannot be ruled out. All related AEs are reported.
| Number of events | Osia 2 System |
|---|---|
| Number of Device or Procedure Related Adverse Events | 15 |
Collected over From the day of surgery (day 0) to 6 months post-surgery. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Osia 2 System | 0/20 (0%) | 0/20 (0%) | 7/20 (35%) |
| Event | Osia 2 System |
|---|---|
| Post-operative painGeneral disorders | 5/20 |
| Post-operative swellingGeneral disorders | 2/20 |
| Age, Continuous(years) | Osia 2 System |
|---|---|
| Mean | 47.9 ± 16.2 |
| Sex: Female, Male(Participants) | Osia 2 System |
|---|---|
| Female | 12 |
| Male | 8 |
| Ethnicity (NIH/OMB)(Participants) | Osia 2 System |
|---|---|
| Hispanic or Latino | 3 |
| Not Hispanic or Latino | 17 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Osia 2 System |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 17 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
| Region of Enrollment(participants) | Osia 2 System |
|---|---|
| United States | 20 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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