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Completed

NCT Number: NCT04823494

Wear-Time Trial for Self-Fitting Hearing Aid

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sertoma Speech and Hearing Center, Palos Hills, Illinois, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

hearing aids

Device

Earbud style hearing aids fit to both ears

Primary outcomes

  1. Aided Abbreviated Profile of Hearing Aid Benefit (APHAB)

    Time frame: 10-14 days

    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 outcomes

  1. Quick Speech in Noise Test (QuickSIN)

    Time frame: Measurement after 10-14-day wear time for each fit.

    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.

Sponsors and collaborators

Lead sponsor

GN Hearing A/S

Industry

Collaborators

  • Northwestern University
  • Sertoma Speech and Hearing Center
  • Vanderbilt University

Registry information

Official study title

Protocol for Self-Fitting Hearing Aid Wear-Time Trial for Listeners With Mild to Moderate Hearing Loss

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 30, 2021
Registry last updated
May 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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