N/A
Completed N=22
Long Term Safety of the Sonitus SoundBite System
Hearing Loss · Unilateral Hearing Loss · Total Unilateral Deafness
Source: ClinicalTrials.gov NCT01108406 ↗
Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcomePrimary: Long Term Safety — 22 participants
Summary
The objective of this study is to assess the long-term safety and quality of life improvement of the Sonitus SoundBite Hearing System.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Long Term Safety |
22 | — |
| SECONDARY Measurement of Device Benefit With the Abbreviated Profile of Hearing Aid Benefit (APHAB) |
21.3; 23.1 | — |
Eligibility Criteria
Inclusion Criteria
- Must be >18, 10dB HL at more than 3 frequencies)
- Word recognition scores inconsistent with pure tone averages
- Fluctuating hearing loss
- Must not have known psychological factors that interfere with their ability to comply, comprehend, consent and cooperate
Data sourced from ClinicalTrials.gov (NCT01108406). 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.