N/A
N=25
Clinical Study of Released Unitron RIC and BTE Hearing Aid Models
Hearing Loss
Bottom Line
View on ClinicalTrials.gov: NCT05197803 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Speech Intelligibility Test in Noise — 0.83; -2.49; -2.74 decibel (dB) Signal-to-Noise Ratio — p=0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hearing aid (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sonova AG
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Speech Intelligibility Test in Noise |
0.83; -2.49; -2.74 | 0.0001 sig |
Summary
The present study will confirm the clinical benefit of 2 different released hearing aid models for speech understanding (in noise). Participants with mild to severe hearing impairment will be fit binaurally with Unitron hearing aids and will perform a standardized speech discrimination test in noise with and without hearing aids.
Eligibility Criteria
Inclusion Criteria
- Adults (18+ years) with hearing impairment (N2 - N6 hearing loss).
- Healthy outer ear.
- Symmetrical hearing loss.
- Ability to answer questions and repeat sentences.
- Informed consent as documented by signature.
- Willingness to wear different style of hearing aids.
- Willingness to wear a binaural fitting.
- Willingness to wear closed domes.
- Willingness to adhere to COVID protocols including correct mask use, completing screening for each visit
Exclusion Criteria
- Contraindications to the medical device (MD) in this study (e.g. known hypersensitivity or allergy to the investigational product).
- Limited mobility/not able to come to scheduled visits.
- Inability to produce reliable hearing test result.
- Visible congenital or traumatic deformity of the outer ear.
- History of active drainage from the ear in the previous 90 days.
- Abnormal appearance of the eardrum and ear canal.
- Acute or chronic dizziness.
- Audiometric air-bone gap equal to or greater than 15 dB at 500 Hz, 1000 Hz, 2000 Hz, and 4000 Hz.
- Known psychological problems.
Data sourced from ClinicalTrials.gov (NCT05197803). 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.