Wear-Time Trial for Self-Fitting Hearing Aid

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.

Inclusion Criteria:

• Mild-to-moderate bilateral sensorineural hearing loss (thresholds from 250 - 8000 Hz less than 60 decibels Hearing Level (dB HL) and from 2000 - 8000 Hz, at least one threshold greater than 20 dB HL)
• Mix of male and female subjects (aiming for a representative balance)
• Mix of prior hearing-aid use (aiming for 70-80% persons with no prior hearing aid use)
• 18-75 years old (aiming for primarily 50-70 years old, with avg. age ~65 years)
• Apple iPhone (iOS 14 compatible or greater, as required for the SELF-FIT app)
• Able to read and comprehend English
• Patient willing to provide informed consent

Exclusion Criteria:

• Hearing outside of limits noted above
• Self-reported ear-related pathology (including chronic severe dizziness or chronic severe tinnitus)