Hearing Loss, Sensorineural
Conditions
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.
Interventions
DEVICEHearing aids
Earbud style hearing aids fit to both ears
Sponsors
Northwestern University
Sertoma Speech and Hearing Center
Vanderbilt University
GN Hearing A/S
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Pre-assignment details
Visit 1 included tests to determine study eligibility and baseline (unaided) performance for outcomes measures obtained after each segment of the crossover field trial (Visits 2 and 3). Eligible subjects were assigned successively to one of two treatment orders at each site for counterbalancing of treatment order. As a result, all 40 enrollees met selection criteria and were assigned to one of the two treatment orders.
Participants by arm
| Arm | Count |
|---|---|
| Pro-Fit Followed by Self-Fit Hearing aids initially fit by a professional hearing care provider using best practices and worn for 10-14 days. Devices then self-fit by participant and worn for 10-14 days.
Hearing aids: Earbud style hearing aids fit to both ears | 19 |
| Self-Fit Followed by Pro-Fit Hearing aids self-fit by patient initially and worn for 10-14 days. Devices then fit by a professional hearing care provider using best practices and worn for another 10-14 days.
Hearing aids: Earbud style hearing aids fit to both ears | 18 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Devices lost | 0 | 1 |
| Overall Study | Programming software malfunction. | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Self-Fit Followed by Pro-Fit | Total | Pro-Fit Followed by Self-Fit |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 18 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 19 Participants | 11 Participants |
| Age, Continuous | 58.67 years STANDARD_DEVIATION 15.11 | 59.84 years STANDARD_DEVIATION 12.13 | 60.95 years STANDARD_DEVIATION 8.71 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 18 Participants | 37 Participants | 19 Participants |
| Sex: Female, Male Female | 9 Participants | 18 Participants | 9 Participants |
| Sex: Female, Male Male | 9 Participants | 19 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 37 |
| other Total, other adverse events | 0 / 37 | 0 / 37 |
| serious Total, serious adverse events | 0 / 37 | 0 / 37 |
Outcome results
Primary
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.
Time frame: 10-14 days
Population: Crossover design. All 37 subjects participated in both Pro-Fit and Self-Fit phases with about half receiving each intervention first. Subjects crossed after 10-14 day field use.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pro-Fit | Aided Abbreviated Profile of Hearing Aid Benefit (APHAB) | 21.35 score on a scale |
| Self-Fit | Aided Abbreviated Profile of Hearing Aid Benefit (APHAB) | 22.76 score on a scale |
Comparison: For the wear-time crossover field trial, the APHAB was measured following both the audiology best-practices hearing aid fitting (PRO-FIT) and the self-fitting method (SELF-FIT).~* Null hypothesis: Mean (APHAB SELF-FIT - APHAB PRO-FIT ) ≥ 8.4~* Alternative hypothesis: Mean (APHAB SELF-FIT - APHAB PRO-FIT) \< 8.4~The mean difference between the aided scores for the two fitting methods, Self-Fit minus Pro-Fit, represent the primary outcome measure. The expected difference = 0.p-value: <0.02595% CI: [-1.59, 4.73]t-test, 1 sided
Secondary
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.
Time frame: Measurement after 10-14-day wear time for each fit.
Population: Crossover design. All 37 subjects participated in both Pro-Fit and Self-Fit phases. Subjects crossed after 10-14 day field use.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pro-Fit | Quick Speech in Noise Test (QuickSIN) | 2.19 score on a scale (dB) |
| Self-Fit | Quick Speech in Noise Test (QuickSIN) | 2.77 score on a scale (dB) |
Comparison: For the QuickSIN, aided performance after each wear period was compared between SELF-FIT and PRO-FIT.~* Null hypothesis: Mean (QuickSIN SELF-FIT - QuickSIPRO-FIT) ≥ 1.5 dB~* Alternative hypothesis: Mean (QuickSIN SELF-FIT - QuickSIN PRO-FIT) \< 1.5 dB~Power calculations were based on the primary outcome measured, the aided APHAB global score, (see information for that outcome measure). With the minimum required N of 32 based on the APHAB global score, the power for QuickSIN exceeded 80%.p-value: <0.02595% CI: [-0.03, 1.2]t-test, 1 sided