N/A
N=38
Evaluation of the Clinical Benefit of the Hearing Aids Tinnitus Feature.
Hearing Loss, Sensorineural · Tinnitus
Bottom Line
View on ClinicalTrials.gov: NCT05292534 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Tinnitus Functional Index Evaluation (TFI) — 35.6; 32; 44.8; 36.2 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- hearing aid amplification (Device); hearing aid amplification with an added sound (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sonova AG
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tinnitus Functional Index Evaluation (TFI) |
35.6; 32; 44.8; 36.2; 34.4; 40.4 | — |
Summary
Participants with hearing loss and Tinnitus will wear hearing aids with amplification-only or with an added sound, and have their tinnitus level evaluated before and after intervention.
Eligibility Criteria
Inclusion Criteria
- Hearing loss
- candidate for hearing aid amplification
- Bothersome chronic tinnitus (3 months+)
Exclusion Criteria
- age less than 18 years
- normal hearing
- tinnitus presence for less than 3 months
- tinnitus not bothersome enough to warrant intervention
- non hearing aid candidates
Data sourced from ClinicalTrials.gov (NCT05292534). 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.