Status:
COMPLETED
Clinical Study of Released Unitron RIC and BTE Hearing Aid Models
Lead Sponsor:
Sonova AG
Collaborating Sponsors:
Sonova Canada Inc.
Conditions:
Hearing Loss
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief 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 bina...
Detailed Description
Each participant will be asked to wear a set of BTE and RIC hearing aids and complete the Hearing in Noise Test (HINT) aided and unaided. The investigators will be assessing their speech intelligibili...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 28 2022
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05197803
Start Date
January 10 2022
End Date
January 28 2022
Last Update
May 7 2025
Active Locations (1)
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1
Unitron Hearing
Kitchener, Ontario, Canada, N2E 1Y6