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Wear-Time Trial for Self-Fitting Hearing Aid

NCT04823494 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-05-11

Study results available
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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

DEVICE

Hearing aids

Earbud style hearing aids fit to both ears

Sponsors & Collaborators

  • Northwestern University

    collaborator OTHER

  • Sertoma Speech and Hearing Center

    collaborator OTHER

  • Vanderbilt University

    collaborator OTHER

  • GN Hearing A/S

    lead INDUSTRY

Principal Investigators

  • Todd Ricketts, Ph.D. · Vanderbilt University

  • Sumitrajit Dhar, Ph.D. · Northwestern University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-18
Primary Completion
2021-09-30
Completion
2021-12-20
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04823494 on ClinicalTrials.gov