Wear-Time Trial for Self-Fitting Hearing Aid

NCT ID: NCT04823494

Last Updated: 2022-05-11

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-18

Study Completion Date

2021-12-20

Brief Summary

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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.

Detailed Description

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Conditions

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Hearing Loss, Sensorineural

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Pro-Fit followed by Self Fit

Hearing aids fit by a professional hearing care provider using best practices followed by patient ...

Group Type EXPERIMENTAL

Hearing aids

Intervention Type DEVICE

Earbud style hearing aids fit to both ears

Self-Fit followed by ProFit

Hearing aids fit by patient followed by ...

Group Type EXPERIMENTAL

Hearing aids

Intervention Type DEVICE

Earbud style hearing aids fit to both ears

Interventions

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Hearing aids

Earbud style hearing aids fit to both ears

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Northwestern University

OTHER

Sponsor Role collaborator

Sertoma Speech and Hearing Center

OTHER

Sponsor Role collaborator

Vanderbilt University

OTHER

Sponsor Role collaborator

GN Hearing A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Todd Ricketts, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Sumitrajit Dhar, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Sertoma Speech and Hearing Center

Palos Hills, Illinois, United States

Site Status

Vanderbilt University

Nashville, Tennessee, United States

Site Status

Countries

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United States

References

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Cox RM, Alexander GC. The abbreviated profile of hearing aid benefit. Ear Hear. 1995 Apr;16(2):176-86. doi: 10.1097/00003446-199504000-00005.

Reference Type BACKGROUND
PMID: 7789669 (View on PubMed)

Killion MC, Niquette PA, Gudmundsen GI, Revit LJ, Banerjee S. Development of a quick speech-in-noise test for measuring signal-to-noise ratio loss in normal-hearing and hearing-impaired listeners. J Acoust Soc Am. 2004 Oct;116(4 Pt 1):2395-405. doi: 10.1121/1.1784440.

Reference Type BACKGROUND
PMID: 15532670 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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X-Men

Identifier Type: -

Identifier Source: org_study_id

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