Efficacy and Effectiveness of an Investigational Behind-the-Ear Hearing Device Kit

Sonova AG20 enrolled

Overview

The goal of this clinical trial is to learn if Sonova's rechargeable behind-the-ear hearing device kit works to treat hearing loss in adults. The main questions it aims to answer are: * Does the rechargeable behind-the-ear hearing device kit address challenging listening situations identified by participants while providing a satisfactory user experience? * Does the rechargeable behind-the-ear hearing device kit improve speech understanding in noise in a lab setting? Researchers will compare participants' performance with the rechargeable behind-the-ear hearing device kit to the unaided condition to see if it works to treat hearing loss. The rechargeable behind-the-ear hearing device kit will be subjectively compared to their personal hearing device experience. Participants will: * Use the rechargeable behind-the-ear hearing device kit for approximately 2 weeks. * Visit the clinic for the initial fitting and follow-up testing at the end of the study. Additional study visits may take place, as needed. * Complete questionnaires to identify challenging listening situations and provide feedback on their experience with the devices. * Complete lab testing to assess speech intelligibility in the presence of background noise and provide subjective feedback on features in the Mobile application.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hearing Loss

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults (aged 18 years or older) * Current and experienced hearing aid users (actively using hearing aids for at least 3 months) * Audiograms that fit within the fitting range of the devices (mild to profound bilateral hearing loss) * Cognitive and functional capability to consent to study procedures, operate the controls for the devices and comply with all directions during the study. * Good understanding (read/write/speak) of the English language. * Willingness to comply with all study requirements including minimum wear-time (6-8 hrs/day) of binaural BTE(RIC) investigational devices. * Good overall health including healthy outer ear with no excessive wax/debris. * Ear canal size/shape must accommodate appropriate fitting of the hearing device. * Socially engaged participants are a top priority (out \& active socially) who frequently encounter the noisy situations in which the devices are meant to be used. * Use/ownership of a smartphone to pair hearing aids with for use with phone calls and streaming. * Otherwise, the study population is representative of typical hearing instrument users in age and presence of hearing loss Exclusion Criteria: * Significant medical conditions that, in the opinion of the investigators, are likely to interfere with study procedures or likely to confound study endpoint. * Contraindications to medical device (MD) in this study: known hypersensitivity or allergy to investigational product/domes. * Limited ability to describe listening impressions/experiences and the use of the hearing aid. * Acute tinnitus (\<three months after onset). * Inability to attend scheduled visits (mobility and/or scheduling).

Outcomes

Primary Outcomes

Subjective questionnaire feedback

Participants will complete subjective feedback questionnaires: Client Oriented Scale of Improvement (COSI), Online questionnaire, Mobile Application questionnaire. Results will be analyzed descriptively to assess the user experience with the hearing device kit.

Time frame: From enrollment to the end of treatment at 2 weeks

Secondary Outcomes

Hearing in Noise Test (HINT)

An assessment of speech understanding in the presence of background noise in the lab setting.

Time frame: At the end of treatment, after two weeks of device use.