Hearing Loss, Sensorineural Clinical Trial
Official title:
Protocol for Self-Fitting Hearing Aid Wear-Time Trial for Listeners With Mild to Moderate Hearing Loss
This document describes a clinical validation study for a double-blind repeated-measures comparative study of the Great Nordic (GN) self-fitting method to a validated audiology-best-practices method when fitting the GN Self-fitting Hearing Aid, a device intended for persons aged 18-75 years old who have mild-to-moderate hearing loss. A crossover wear-time field trial will be conducted. The focus of the study is on the validity of the self-fitting process used to select appropriate frequency-gain characteristics for the GN Self-fitting Hearing Aid, and the safety and effectiveness of the device.
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