Clinical Study of Released Unitron RIC and BTE Hearing Aid Models

Study Overview
=================
Brief 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.

Detailed 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).

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

Conditions
-----------------
Hearing Loss

Intervention / Treatment
-----------------
* Device: Hearing aid model


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 1 group with three randomized conditions (unaided, aided with RIC, aided with BTE).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hearing aid model<br>Unaided, Unitron RIC and Unitron BTE hearing aid styles during one-time visit. | Device: Hearing aid model<br>* Amplification<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |