N/A
Completed N=16
Home Test of New Sound Processor
Source: ClinicalTrials.gov NCT04559282 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcomePrimary: Hearing Performance of Speech in Noise for Unaided Hearing and the Baha 6 Max Assessed Via Adaptive Speech Test in Noise — -3.7; 4.8 db SNR (decibel Speech in Noise Ratio)
Summary
The purpose of this clinical investigation is to test a new Sound Processor (SP) to compare hearing performance of the new Sound Processor with unaided hearing and Baha 5 SP in adult subjects and to investigate which device (new Sound Processor versus Baha 5) the subjects prefer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hearing Performance of Speech in Noise for Unaided Hearing and the Baha 6 Max Assessed Via Adaptive Speech Test in Noise |
-3.7; 4.8 | — |
| PRIMARY Participant Preference for the Baha 6 Max or Baha 5 SP Assessed Via Questions in the eCRF |
13; 3 | — |
| SECONDARY Descriptive Hearing Performance for the Baha 6 Max and Baha 5 SP in a Home/Normal Hearing Environment Assessed Via a Diary |
13; 9; 2; 6; 1; 1 | — |
| SECONDARY Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Adaptive Speech Test in Noise |
-3.7; -2.8 | — |
| SECONDARY Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry |
29.7; 34.1; 20.9; 24.1; 20.3; 23.1 | — |
| SECONDARY Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Speech Test in Quiet |
88.4; 77.9 | — |
| SECONDARY Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Participant Rating |
3.0; 2.6; 2.8; 2.6; 4.69; 4.63 | — |
| SECONDARY Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Internal Noise |
1; 0; 15; 16; 0; 0 | — |
| SECONDARY Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Listening Effort. |
1.97; 3.02 | — |
| SECONDARY Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry |
29.7; 46.3; 20.9; 49.7; 20.3; 54.4 | — |
| SECONDARY Hearing Performance for Baha 6 Max and Unaided Assessed Via Speech Test in Quiet |
88.4; 11 | — |
Eligibility Criteria
Inclusion Criteria
- Adult subject (18-<70 years of age)
- At least 12 months experience from using a Baha Connect system (percutaneous Baha)
- Subject with a conductive or mild to moderate mixed hearing loss. that would benefit from improved hearing from bone conduction device as judged by the research audiologist
- Willing and able to provide written informed consent
Exclusion Criteria
- Signs of infection around the implant site
- Unable to follow investigational procedures
- Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator
- Investigator site personnel directly affiliated with this investigation and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
- Cochlear employees
- Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
Data sourced from ClinicalTrials.gov (NCT04559282). 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. Informational only — not medical advice.