Hearing Aid Quality and Reliability Study

A study testing Phonak Audeo hearing aid in people with Hearing Loss, run by Sonova AG at 1 site in United States.

Completed

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

Trial summary

Quality and reliability study of hearing aid. Adults with mild to severe hearing loss will wear hearing aids daily for approximately 3 months. Read more about this study

Who is it for?: Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for: Hearing Loss
What is being tested?: Phonak Audeo hearing aid
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 1 siteUnited States
Study dates: 8 Jun 2021to 31 Oct 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 90 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Adults with mild to moderate severe sensorineural hearing loss
Adults who were able to incorporate some type of physical activity into their day (i.e walking, excercise, gardening, etc.)

Who cannot join

Unable or unwilling to wear study devices during a home trial
Unable or unwilling to come to lab for study visits

Trial locations and contacts

1 site in 1 country.

United States1 site

Sonova
Aurora, Illinois, 60504

Other trials in United States

About this study

Official title: Hearing Aid Quality Check and Reliability Study

Quality and reliability study of hearing aid. Adults with mild to severe hearing loss will wear hearing aids daily for approximately 3 months.

Conditions: Hearing Loss
Being tested: Phonak Audeo hearing aid
Medical subject headings: Hearing Loss

What participants receive

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

Phonak Audeo hearing aidDevice
Rechargeable hearing aid

Study groups in NCT04995666
Study group	Role	What they receive
Hearing Aid	Experimental	Participants will wear Phonak rechargeable Audeo hearing aids Receives: Device: Phonak Audeo hearing aid

What is being measured

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

Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 1
Test box electroacoustic measurements of hearing aid done at full on settings must meet manufacturer product specifications per manufacturer data sheet. This includes maximum and high frequency average output sound pressure level, maximum and high frequency average acoustic gain, frequency response range, total harmonic distortion and equivalent input noise level. This is done using an Audioscan Verifit2 electroacoustic analyzer.
Electroacoustic measurements listed above will also be taken with hearing aid set to user settings, as a baseline measure for all future appointments.
Measured: Day 1 of study
Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 45
Test box electroacoustic measurements (using the Audioscan Verifit 2 Electroacoustic Analyzer) of hearing aid done at user gain settings after daily use for extended period of time. Results will be compared to baseline electroacoustic measures taken on day 1 of study. A "pass" means that devices were within tolerance levels (per ANSI S3.22-2014) of baseline measures. A "fail" means that devices were not within tolerance levels of one or more baseline measures (i.e. output, gain, frequency range, total harmonic distortion, or equivalent input noise level).
Measured: Day 45 of study
Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 90
Test box electroacoustic measurements of hearing aid done at user gain settings after daily use for extended period of time. Test box electroacoustic measurements of hearing aid done at user gain settings after daily use for extended period of time. Results will be compared to baseline electroacoustic measures taken on day 1 of study. A "pass" means that devices were within tolerance levels (per ANSI S3.22-2014) of baseline measures. A "fail" means that devices were not within tolerance levels of one or more baseline measures (i.e. output, gain, frequency range, total harmonic distortion, or equivalent input noise level).
Measured: Day 90 of study

Timeline

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

8 Jun 202131 Oct 2021

First posted9 Aug 2021
Study start8 Jun 2021
Primary completion13 Sep 2021
Study completion31 Oct 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.
Other trials for Hearing LossStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04995666
Sponsor's protocol ID: SRF-368
Status last verified: Apr 2023
First submitted: 11 Jun 2021
Last updated: 17 May 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

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

RecruitingObservational study
Natural History of Autosomal Dominant Hearing Loss
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Mi2000 TICI - Post-market Implantation Study
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Assessing Pharmacy Technician Educational Training for the Provision of Over-the-Counter Hearing Aids in Rural Alabama and Mississippi Pharmacies
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Enrolling by invitation
Self-monitoring of Hearing Aids Using Artificial Intelligence
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All Hearing Loss trials

Study at a glance

From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Hearing Aid Quality Check and Reliability Study
ClinicalTrials.gov ID: NCT04995666
Acronym / sponsor ID: SRF-368
Conditions: Hearing Loss
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: Sonova AGIndustry (pharma, biotech, devices)
Study start: 8 Jun 2021 (actual)
Primary completion: 13 Sep 2021 (actual)
Study completion: 31 Oct 2021 (actual)
First posted: 9 Aug 2021 (actual)
Results: Posted 17 May 2023

Clinical summary

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

Quality and reliability study of hearing aid. Adults with mild to severe hearing loss will wear hearing aids daily for approximately 3 months.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Hearing Aid	Experimental	Device: Phonak Audeo hearing aidParticipants will wear Phonak rechargeable Audeo hearing aids

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Adults with mild to moderate severe sensorineural hearing loss
Adults who were able to incorporate some type of physical activity into their day (i.e walking, excercise, gardening, etc.)

Key exclusion criteria (2 listed)

Unable or unwilling to wear study devices during a home trial
Unable or unwilling to come to lab for study visits

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
Phonak Audeo hearing aidRechargeable hearing aid	Device	Hearing Aid

Primary outcome

Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 1
Time frame: Day 1 of study
Test box electroacoustic measurements of hearing aid done at full on settings must meet manufacturer product specifications per manufacturer data sheet. This includes maximum and high frequency average output sound pressure level, maximum and high frequency average acoustic gain, frequency response range, total harmonic distortion and equivalent input noise level. This is done using an Audioscan Verifit2 electroacoustic analyzer. Electroacoustic measurements listed above will also be taken with hearing aid set to user settings, as a baseline measure for all future appointments.
Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 45
Time frame: Day 45 of study
Test box electroacoustic measurements (using the Audioscan Verifit 2 Electroacoustic Analyzer) of hearing aid done at user gain settings after daily use for extended period of time. Results will be compared to baseline electroacoustic measures taken on day 1 of study. A "pass" means that devices were within tolerance levels (per ANSI S3.22-2014) of baseline measures. A "fail" means that devices were not within tolerance levels of one or more baseline measures (i.e. output, gain, frequency range, total harmonic distortion, or equivalent input noise level).
Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 90
Time frame: Day 90 of study
Test box electroacoustic measurements of hearing aid done at user gain settings after daily use for extended period of time. Test box electroacoustic measurements of hearing aid done at user gain settings after daily use for extended period of time. Results will be compared to baseline electroacoustic measures taken on day 1 of study. A "pass" means that devices were within tolerance levels (per ANSI S3.22-2014) of baseline measures. A "fail" means that devices were not within tolerance levels of one or more baseline measures (i.e. output, gain, frequency range, total harmonic distortion, or equivalent input noise level).

Results and safety

Results posted to the registry on 17 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Hearing Aid	19	19

Primary outcome: Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 1

Time frame: Day 1 of study. Count of units. Unit: hearing aid devices

Measure	Hearing Aid n = 19
Number of units that PASS manufacturer specifications	38
Number of units that FAIL manufacturer specifications	0

Population analysed: All devices dispensed to study participants on day 1 of study tested on electroacoustic verification equipment

Primary outcome: Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 45

Time frame: Day 45 of study. Count of units. Unit: hearing aid devices

Measure	Hearing Aid n = 19
Number of devices that PASS manufacturer specifications specifications	38
Number of devices that FAIL manufacturer specifications	0

Population analysed: All devices dispensed to study participants on day 1 of study tested on electroacoustic verification equipment

Primary outcome: Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 90

Time frame: Day 90 of study. Count of units. Unit: hearing aid devices

Measure	Hearing Aid n = 19
Number of devices that PASS manufacturer specifications	35
Number of devices that FAIL manufacturer specifications	2

Population analysed: All devices dispensed to study participants on day 1 of study tested on electroacoustic verification equipment. One participant lost a device, therefore total number of devices analyzed on Day 90 is 37.

Adverse events

Time frame: 90 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Hearing Aid	0 of 19 (0%)	1 of 19 (5.3%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Hearing Loss

RecruitingObservational study
Natural History of Autosomal Dominant Hearing Loss
Hearing Loss
Recruiting
Fall Risk Assessment and Speech Intelligibility Enhancement Using In-ear Device
Hearing Loss, Dizziness
Not yet recruiting
Mi2000 TICI - Post-market Implantation Study
Hearing Loss, Binaural, Cochlear Implantation
Recruiting
Assessing Pharmacy Technician Educational Training for the Provision of Over-the-Counter Hearing Aids in Rural Alabama and Mississippi Pharmacies
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Enrolling by invitation
Self-monitoring of Hearing Aids Using Artificial Intelligence
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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A study testing Phonak Audeo hearing aid in people with Hearing Loss, run by Sonova AG at 1 site 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 2 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 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 17 May 2023). 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?

Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 1 (time frame: Day 1 of study). The study lists 3 primary outcomes in all. 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 NCT04995666.

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 17 May 2023; AzTrials last refreshed its copy on 28 Oct 2026.