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Wear-Time Trial for Self-Fitting Hearing Aid

Primary Purpose

Hearing Loss, Sensorineural

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hearing aids
Sponsored by
GN Hearing A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss, Sensorineural

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Sertoma Speech and Hearing Center
  • Vanderbilt University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Pro-Fit followed by Self Fit

Self-Fit followed by ProFit

Arm Description

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

Hearing aids fit by patient followed by ...

Outcomes

Primary Outcome Measures

Aided Abbreviated Profile of Hearing Aid Benefit (APHAB)
The APHAB is a 24-item self-assessment of the amount of trouble the respondent has with communication in everyday situations. Sample question: "When I'm at the dinner table with several people, and I am trying to have a conversation with one person, understanding speech is difficult." For each of the 24 items, person asked to select one of the following percentages to indicate how frequently this occurs: Always (99%); Almost Always (87%); Generally (75%); Half-the-time (50%); Occasionally (25%); Seldom (12%); or Never (1%). Mean scale scores are expressed as a percentage or proportion representing the average frequency of difficulty experienced. An APHAB global score based on the 18 items from the three speech-communication subscales was used in the statistical analyses. APHAB scores were obtained unaided (Visit 1) and following use of the hearing aids for 10-14 days for each fit (Visits 2 & 3; aided). The primary outcome is the mean difference in aided scores, Self-Fit minus Pro-Fit.

Secondary Outcome Measures

Quick Speech in Noise Test (QuickSIN)
The QuickSIN test consists of lists of six sentences played from a loudspeaker at a constant level approximating typical conversation. The level of the co-located four-talker babble (background noise) increased across the six sentences for signal-to-noise ratios (SNRs) ranging from +25 to 0 decibels (dB) SNR (in steps of 5 dB). The participant was asked to repeat each sentence. The examiner scored predetermined key words in each sentence. The resulting score was interpreted as an SNR loss in dB where a value near 0 dB indicates normal hearing and larger values indicate more difficulty listening in noise. The QuickSIN SNR values for the Pro-Fit condition were subtracted from those for the Self-Fit condition to generate a difference value in dB between the two fitting methods. The secondary outcome measure evaluated here was the mean difference in QuickSIN SNR values in dB between Pro-Fit and Self-Fit for all 37 participants; 19 Pro-Fit first and 18 Self-Fit first.

Full Information

First Posted
March 26, 2021
Last Updated
April 18, 2022
Sponsor
GN Hearing A/S
Collaborators
Northwestern University, Sertoma Speech and Hearing Center, Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT04823494
Brief Title
Wear-Time Trial for Self-Fitting Hearing Aid
Official Title
Protocol for Self-Fitting Hearing Aid Wear-Time Trial for Listeners With Mild to Moderate Hearing Loss
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 18, 2021 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
December 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GN Hearing A/S
Collaborators
Northwestern University, Sertoma Speech and Hearing Center, Vanderbilt University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Sensorineural

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pro-Fit followed by Self Fit
Arm Type
Experimental
Arm Description
Hearing aids fit by a professional hearing care provider using best practices followed by patient ...
Arm Title
Self-Fit followed by ProFit
Arm Type
Experimental
Arm Description
Hearing aids fit by patient followed by ...
Intervention Type
Device
Intervention Name(s)
Hearing aids
Intervention Description
Earbud style hearing aids fit to both ears
Primary Outcome Measure Information:
Title
Aided Abbreviated Profile of Hearing Aid Benefit (APHAB)
Description
The APHAB is a 24-item self-assessment of the amount of trouble the respondent has with communication in everyday situations. Sample question: "When I'm at the dinner table with several people, and I am trying to have a conversation with one person, understanding speech is difficult." For each of the 24 items, person asked to select one of the following percentages to indicate how frequently this occurs: Always (99%); Almost Always (87%); Generally (75%); Half-the-time (50%); Occasionally (25%); Seldom (12%); or Never (1%). Mean scale scores are expressed as a percentage or proportion representing the average frequency of difficulty experienced. An APHAB global score based on the 18 items from the three speech-communication subscales was used in the statistical analyses. APHAB scores were obtained unaided (Visit 1) and following use of the hearing aids for 10-14 days for each fit (Visits 2 & 3; aided). The primary outcome is the mean difference in aided scores, Self-Fit minus Pro-Fit.
Time Frame
10-14 days
Secondary Outcome Measure Information:
Title
Quick Speech in Noise Test (QuickSIN)
Description
The QuickSIN test consists of lists of six sentences played from a loudspeaker at a constant level approximating typical conversation. The level of the co-located four-talker babble (background noise) increased across the six sentences for signal-to-noise ratios (SNRs) ranging from +25 to 0 decibels (dB) SNR (in steps of 5 dB). The participant was asked to repeat each sentence. The examiner scored predetermined key words in each sentence. The resulting score was interpreted as an SNR loss in dB where a value near 0 dB indicates normal hearing and larger values indicate more difficulty listening in noise. The QuickSIN SNR values for the Pro-Fit condition were subtracted from those for the Self-Fit condition to generate a difference value in dB between the two fitting methods. The secondary outcome measure evaluated here was the mean difference in QuickSIN SNR values in dB between Pro-Fit and Self-Fit for all 37 participants; 19 Pro-Fit first and 18 Self-Fit first.
Time Frame
Measurement after 10-14-day wear time for each fit.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd Ricketts, Ph.D.
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sumitrajit Dhar, Ph.D.
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sertoma Speech and Hearing Center
City
Palos Hills
State/Province
Illinois
ZIP/Postal Code
60465
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37235
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
7789669
Citation
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.
Results Reference
background
PubMed Identifier
15532670
Citation
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. Erratum In: J Acoust Soc Am. 2006 Mar;119(3):1888.
Results Reference
background

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Wear-Time Trial for Self-Fitting Hearing Aid

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