Hearing Loss, SensorineuralNCT04823494

Wear-Time Trial for Self-Fitting Hearing Aid

A study testing Hearing aids in people with Hearing Loss, Sensorineural, run by GN Hearing A/S at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Hearing Loss, Sensorineural
What is being tested?: Hearing aids
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 2 sitesUnited States
Study dates: 18 Jun 2021to 20 Dec 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

Hearing outside of limits noted above
Self-reported ear-related pathology (including chronic severe dizziness or chronic severe tinnitus)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Vanderbilt University
Nashville, Tennessee, 37235
Sertoma Speech and Hearing Center
Palos Hills, Illinois, 60465

Other trials in United States

About this study

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

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.

Conditions: Hearing Loss, Sensorineural
Being tested: Hearing aids
Medical subject headings: Hearing Loss, Sensorineural

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hearing aidsDevice
Earbud style hearing aids fit to both ears

Study groups in NCT04823494
Study group	Role	What they receive
Pro-Fit followed by Self Fit	Experimental	Hearing aids fit by a professional hearing care provider using best practices followed by patient ... Receives: Device: Hearing aids
Self-Fit followed by ProFit	Experimental	Hearing aids fit by patient followed by ... Receives: Device: Hearing aids

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 10-14 days

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Jun 202120 Dec 2021

First posted30 Mar 2021
Study start18 Jun 2021
Primary completion30 Sep 2021
Study completion20 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Hearing Loss, SensorineuralStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04823494
Sponsor's protocol ID: X-Men
Status last verified: Mar 2022
First submitted: 26 Mar 2021
Last updated: 11 May 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 7789669
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.
PubMed 15532670

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
Enrolling by invitationObservational study
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
Sensorineural Hearing Loss, Tinnitus
Active, not recruiting
An Investigation to Evaluate Sound Coding Enhancements in Adult Cochlear Implant Recipients
Cochlear Implant Recipients, Hearing Loss, Cochlear
RecruitingPhase 2
Efficacy and Safety of Hydroxychloroquine in the Treatment of Sudden Sensorineural Hearing Loss
Sudden Hearing Loss
RecruitingObservational study
Cisplatin-induced Cochlear and Vestibular Damage in Head and Neck Cancer
Ototoxic Hearing Loss, Ototoxicity, Drug-Induced

All Hearing Loss, Sensorineural trials

Study at a glance

From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Protocol for Self-Fitting Hearing Aid Wear-Time Trial for Listeners With Mild to Moderate Hearing Loss
ClinicalTrials.gov ID: NCT04823494
Acronym / sponsor ID: X-Men
Conditions: Hearing Loss, Sensorineural
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: GN Hearing A/SIndustry (pharma, biotech, devices)
Collaborators: Northwestern University, Sertoma Speech and Hearing Center, Vanderbilt University
Study start: 18 Jun 2021 (actual)
Primary completion: 30 Sep 2021 (actual)
Study completion: 20 Dec 2021 (actual)
First posted: 30 Mar 2021 (actual)
Results: Posted 11 May 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Crossover
Masking: Double blind (participant, care provider)
Number of arms: 2

Arm	Type	Receives
Pro-Fit followed by Self Fit	Experimental	Device: Hearing aidsHearing aids fit by a professional hearing care provider using best practices followed by patient ...
Self-Fit followed by ProFit	Experimental	Device: Hearing aidsHearing aids fit by patient followed by ...

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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)

Key exclusion criteria (2 listed)

Hearing outside of limits noted above
Self-reported ear-related pathology (including chronic severe dizziness or chronic severe tinnitus)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hearing aidsEarbud style hearing aids fit to both ears	Device	Pro-Fit followed by Self Fit, Self-Fit followed by ProFit

Primary outcome

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.

1 secondary outcome

Quick Speech in Noise Test (QuickSIN)
Time frame: Measurement after 10-14-day wear time for each fit.

Results and safety

Results posted to the registry on 11 May 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pro-Fit Followed by Self-Fit	21	19
Self-Fit Followed by Pro-Fit	19	18

Primary outcome: Aided Abbreviated Profile of Hearing Aid Benefit (APHAB)

Time frame: 10-14 days. Mean (95% Confidence Interval). Unit: score on a scale

Measure	Pro-Fit n = 37	Self-Fit n = 37
Value	21.35 (16.78 to 26.33)	22.76 (18.33 to 27.59)

Pro-Fit vs Self-Fit: Mean Difference (Final Values): 1.4 (95% CI -1.59 to 4.73), p <0.025, t-test, 1 sided

Population analysed: 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.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pro-Fit	0 of 37 (0%)	0 of 37 (0%)	0 of 37
Self-Fit	0 of 37 (0%)	0 of 37 (0%)	0 of 37

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 7789669Cox RM, Alexander GC. The abbreviated profile of hearing aid benefit. Ear Hear. 1995 Apr;16(2):176-86. doi: 10.1097/00003446-199504000-00005.
Background: PubMed 15532670Killion 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.
Individual participant dataSharing planned: No

Related trials for Hearing Loss, Sensorineural

Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
Enrolling by invitationObservational study
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
Sensorineural Hearing Loss, Tinnitus
Active, not recruiting
An Investigation to Evaluate Sound Coding Enhancements in Adult Cochlear Implant Recipients
Cochlear Implant Recipients, Hearing Loss, Cochlear
RecruitingPhase 2
Efficacy and Safety of Hydroxychloroquine in the Treatment of Sudden Sensorineural Hearing Loss
Sudden Hearing Loss
RecruitingObservational study
Cisplatin-induced Cochlear and Vestibular Damage in Head and Neck Cancer
Ototoxic Hearing Loss, Ototoxicity, Drug-Induced

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Todd Ricketts, Ph.D. principal investigator

Vanderbilt University

Sumitrajit Dhar, Ph.D. principal investigator

Northwestern University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Hearing aids in people with Hearing Loss, Sensorineural, run by GN Hearing A/S at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Aided Abbreviated Profile of Hearing Aid Benefit (APHAB) (time frame: 10-14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04823494, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.