Clinical Study of Released Unitron RIC and BTE Hearing Aid Models

Sonova

Status: Completed

Conditions: Hearing Loss

Treatments: Device: Hearing aid

Study type: Interventional

Funder types: Industry

Identifiers

NCT05197803

515

Details and patient eligibility

About

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.

Full 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).

Enrollment: 25 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Experimental

Experimental group

Description:

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.

Treatment:

Device: Hearing aid