Evaluation of Efficacy and Effectiveness of the Investigational Sonova Behind-the-Ear Rechargeable Hearing Device Kit 2 - 2025
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.
• 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