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| Name | Class |
|---|---|
| Northwestern University | OTHER |
| Sertoma Speech and Hearing Center | OTHER |
| Vanderbilt University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pro-Fit followed by Self Fit | Experimental | Hearing aids fit by a professional hearing care provider using best practices followed by patient ... |
|
| Self-Fit followed by ProFit | Experimental | Hearing aids fit by patient followed by ... |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hearing aids | Device | Earbud style hearing aids fit to both ears |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Todd Ricketts, Ph.D. | Vanderbilt University | Principal Investigator |
| Sumitrajit Dhar, Ph.D. | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sertoma Speech and Hearing Center | Palos Hills | Illinois | 60465 | United States | ||
| Vanderbilt University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7789669 | Background | 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. | |
| 15532670 | Background | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pro-Fit Followed by Self-Fit | Hearing aids fit by a professional hearing care provider using best practices, followed by a self-fit of both devices. There was a 10-14-day wear period following each fitting method. Hearing aids: Earbud style hearing aids fit to both ears |
| FG001 | Self-Fit Followed by Pro-Fit | Hearing aids self-fit by participant followed by the fitting of the devices by a professional hearing care provider using best practices. There was a 10-14-day wear period following each fitting method. Hearing aids: Earbud style hearing aids fit to both ears |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
37 subjects completed both Pro-Fit and Self-Fit conditions in a counterbalanced order. Subjects switched conditions after the first of two wear time trials. There were a total of 37 subjects tested.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Self-Fit Followed by Pro-Fit |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 10-14 days |
The time from eligibility and baseline measures at Visit 1 through the completion of the outcome measures after the second wear period was 3-5 weeks. Adverse events were collected over this time frame for each participant.
One potential adverse effect was an adjustment of gain that could result in uncomfortable loudness. However, this was prevented automatically for all participants by limiting the maximum output of the devices.
The app used to fit and control the device requires some familiarity with apps and the user may experience some frustration with these procedures initially.
Adverse events and serious adverse events were monitored throughout the study for all participants. None were recorded.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pro-Fit | Hearing aids fit by a professional hearing care provider using best practices and worn for 10-14 days. Hearing aids: Earbud style hearing aids fit to both ears |
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The minimum N needed to achieve the desired statistical power was 32 and 40 participants were enrolled to allow for attrition. In the end, only 3 participants were exited from the study or withdrew, leaving 37 with complete data. Of the 3 with incomplete data, 2 resulted from technical issues with the devices or app. However, both per-protocol analyses (summarized above) and intention-to-treat analyses yielded the same findings, indicating that the few missing data were inconsequential.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Todd Fortune | GN | 763-772-5566 | tfortune@gnresound.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 3, 2021 | Feb 2, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D006310 | Hearing Aids |
| ID | Term |
|---|---|
| D000076251 | Wearable Electronic Devices |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D012682 | Sensory Aids |
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| Measurement after 10-14-day wear time for each fit. |
| Nashville |
| Tennessee |
| 37235 |
| United States |
| Devices lost |
|
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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Pro-Fit | Hearing aids fit by a professional hearing care provider using best practices and worn for 10-14 days prior to outcomes measurement. Hearing aids: Earbud style hearing aids fit to both ears |
| OG001 | Self-Fit | Hearing aids self-fit by participant and worn 10-14 days prior to outcomes measurement. Hearing aids: Earbud style hearing aids fit to both ears |
|
|
|
| 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. | Crossover design. All 37 subjects participated in both Pro-Fit and Self-Fit phases. Subjects crossed after 10-14 day field use. | Posted | Mean | 95% Confidence Interval | score on a scale (dB) | Measurement after 10-14-day wear time for each fit. |
|
|
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| 0 |
| 37 |
| EG001 | Self-Fit | Hearing aids self-fit by participant and worn for 10-14 days. Hearing aids: Earbud style hearing aids fit to both ears | 0 | 37 | 0 | 37 | 0 | 37 |
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| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Mean differences in aided QuickSIN SNR in dB, Self-Fit minus Pro-Fit, were calculated for the entire group of 37 participants with about 1/2 receiving one of the two fit sequences (Pro-Fit then Self-Fit or Self-Fit then Pro-Fit). |
| Non-Inferiority |
For the QuickSIN, a clinically meaningful difference is 3 dB and half that difference resulted in a margin of 1.5 dB. This 1.5-dB margin was used for the QuickSIN for the non-inferiority analyses of the data from the field-trial component. The mean difference, QuickSIN Self-Fit minus QuickSIN Pro-Fit, should be less than 1.5 dB for the entire sample (N=37) to meet the non-inferiority criterion. |