Clinical Study of Released Unitron RIC and BTE Hearing Aid Models

NCT ID: NCT05197803

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-10
• Study Completion Date: 2022-01-28

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 binaurally with Unitron hearing aids and will perform a standardized speech discrimination test in noise with and without hearing aids.

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 intelligibility in noise for each condition during the same appointment to determine the SNR50 (the Signal-to-Noise ratio necessary for a participant to recognize the speech material correctly 50 percent of the time).

Conditions

Hearing Loss

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental

The same group of participants undergo the same testing conditions. Each participant is fit with the BTE and the RIC hearing aids and then complete the speech intelligibility testing - Hearing in Noise Test (HINT) - aided and unaided during one-time visit.

Group Type: EXPERIMENTAL

Hearing aid

Intervention Type: DEVICE

Participants will complete testing aided and unaided. The hearing aids have been fit to compensate for their hearing loss.

Interventions

Hearing aid

Participants will complete testing aided and unaided. The hearing aids have been fit to compensate for their hearing loss.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sonova Canada Inc.

INDUSTRY

Sponsor Role: collaborator

Sonova AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jinyu Qian, PhD

Role: PRINCIPAL_INVESTIGATOR

jinyu.qian@sonova.com

Locations

Unitron Hearing

Kitchener, Ontario, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

515

Identifier Type: -

Identifier Source: org_study_id