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.

Study Overview

• Status: Completed
• Conditions: Hearing Loss, Sensorineural
• Intervention / Treatment: Device: Hearing aids

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Palos Hills, Illinois, United States, 60465
      • Sertoma Speech and Hearing Center
  • Tennessee
    • Nashville, Tennessee, United States, 37235
      • Vanderbilt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Pro-Fit followed by Self Fit; Hearing aids fit by a professional hearing care provider using best practices followed by patient ...	Device: Hearing aids; Earbud style hearing aids fit to both ears
EXPERIMENTAL: Self-Fit followed by ProFit; Hearing aids fit by patient followed by ...	Device: Hearing aids; Earbud style hearing aids fit to both ears

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10-14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Measurement after 10-14-day wear time for each fit.

Collaborators and Investigators

• Sponsor: GN Hearing A/S
• Collaborators: Northwestern University; Vanderbilt University; Sertoma Speech and Hearing Center
• Investigators: Principal Investigator: Todd Ricketts, Ph.D., Vanderbilt University; Principal Investigator: Sumitrajit Dhar, Ph.D., Northwestern University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 18, 2021
• Primary Completion (ACTUAL): September 30, 2021
• Study Completion (ACTUAL): December 20, 2021

Study Registration Dates

• First Submitted: March 26, 2021
• First Submitted That Met QC Criteria: March 26, 2021
• First Posted (ACTUAL): March 30, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 11, 2022
• Last Update Submitted That Met QC Criteria: April 18, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Sensorineural
• Other Study ID Numbers: X-Men

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No