Clinical Study of Released Unitron RIC and BTE Hearing Aid Models

Not Applicable

Completed

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).

Recruitment & 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.

Arm && Interventions

Group	Intervention	Description
Hearing aid model	Hearing aid model	Unaided, Unitron RIC and Unitron BTE hearing aid styles during one-time visit.

Primary Outcome Measures

Name	Time	Method
Speech Intelligibility Test in Noise	2 hours appointment	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.

Secondary Outcome Measures