Clinical Study of Released Unitron RIC and BTE Hearing Aid Models

Hearing Loss Clinical Trial

Official title:

Clinical Study of Released Unitron RIC (Receiver in Canal) and BTE (Behind the Ear) Hearing Aid Models

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05197803
• Other study ID #: 515
• Status: Completed
• Phase: N/A
• Start date: January 4, 2022
• Est. completion date: February 28, 2022

Study information

• Verified date: April 2022
• Source: Sonova AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Participants will wear two sets of Unitron released hearing aids (RIC and BTE) programmed based on a prescriptive approach and will perform a standardized speech discrimination test in noise in both aided conditions as well as in unaided condition.

Description:

During this study each participant will be asked to complete three randomized conditions of the HINT testing: unaided, aided with RIC, and aided with BTE. The investigators will be assessing their speech intelligibility in noise in each condition, during the same appointment to determine the SNR-50 (the Signal-to-Noise ratio necessary for a participant to recognize the speech material correctly 50 percent of the time).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• Hearing aid model
Amplification

Locations

Country	Name	City	State
Canada	Unitron Hearing	Kitchener	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sonova AG	Sonova Canada Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SNR-50	Obtain SNR-50 for each participant from the HINT for the three investigational conditions. Results from the unaided condition will be compared against each of the aided condition. No comparison will be done between aided conditions. It is expected for participants to have lower SNR scores (better) when wearing hearing aids than compared to unaided performance.	2 hours appointment