Hearing Loss
Conditions
Brief summary
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.
Interventions
DEVICERechargeable behind-the-ear hearing device kit
This intervention includes the following components: hearing aid, charger, applicable accessories
Sponsors
Sonova AG
National Hearing Services Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective questionnaire feedback | From enrollment to the end of treatment at 2 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hearing in Noise Test (HINT) | At the end of treatment, after two weeks of device use. | An assessment of speech understanding in the presence of background noise in the lab setting. |
Countries
Canada
Outcome results
None listed