NCT04823494

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: GN Hearing A/S · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Hearing Loss, Sensorineural

Interventions

Type	Name	Description
DEVICE	Hearing aids	Earbud style hearing aids fit to both ears

Timeline

• Start date: 2021-06-18
• Primary completion: 2021-09-30
• Completion: 2021-12-20
• First posted: 2021-03-30
• Last updated: 2022-05-11
• Results posted: 2022-05-11

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study