Wear-Time Trial for Self-Fitting Hearing Aid

Not Applicable

Completed

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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
Self-Fit followed by ProFit	Hearing aids	Hearing aids fit by patient followed by ...
Pro-Fit followed by Self Fit	Hearing aids	Hearing aids fit by a professional hearing care provider using best practices followed by patient ...

Primary Outcome Measures

Name	Time	Method
Aided Abbreviated Profile of Hearing Aid Benefit (APHAB)	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 Outcome Measures

Name	Time	Method
Quick Speech in Noise Test (QuickSIN)	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.

Locations (2): Vanderbilt University
🇺🇸
Nashville, Tennessee, United States
Sertoma Speech and Hearing Center
🇺🇸
Palos Hills, Illinois, United States