Clinical Study of Released Unitron RIC and BTE Hearing Aid Models

NCT05197803 | Completed Results

• 1 other identifier: 515
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

• Speech Intelligibility Test in Noise

  Sentences are presented through a speaker in front of the participant's head. Background noise is presented through other seven speakers arranged around the participant. The senteces are presented at varying levels (both louder and softer) than the fixed level of the noise. The SNR50 is the Signal-to-Noise Ratio (SNR) expressed in decibels (dB) at which the participant can repeat 50% of the words correctly. For example, an SNR50 of +3 means that the participant repeated 50% of the words back correctly when the sentences were presented at a level that was 3dB louder than the noise. Lower scores indicate better performance.

  2 hours appointment

Study Arms (1)

Experimental

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.

Device: Hearing aid

Interventions

Hearing aid DEVICE

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

Experimental

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sonova AG: lead
• Sonova Canada Inc.: collaborator

Study Sites (1)

Unitron Hearing

Kitchener, Ontario, N2E 1Y6, Canada

Location

MeSH Terms

Conditions

Hearing Loss

Interventions

Hearing Aids

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies; Sensory Aids

Results Point of Contact

• Title: Study Manager
• Organization: Sonova AG

carolina.rubiano@sonova.com

519 895 0100

Study Officials

• Jinyu Qian, PhD

  jinyu.qian@sonova.com

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: One similar intervention; 2 groups based on hearing aid model.

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: January 20, 2022
• Study Start: January 10, 2022
• Primary Completion: January 28, 2022
• Study Completion: January 28, 2022
• Last Updated: May 7, 2025
• Results First Posted: May 7, 2025

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)