Wear-Time Trial for Self-Fitting Hearing Aid

Study Overview
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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.

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

Conditions
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Hearing Loss, Sensorineural

Intervention / Treatment
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* Device: Hearing aids


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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. |