Hearing LossNCT04787055

In Field Performance of a Hearing Aid Transducer

A study testing Receiver-in-canal hearing instrument 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.

Official record

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Trial summary

Study participants will be fit with previously released receiver-in-canal (RIC) hearing instruments. Participants will be asked to wear the instruments in their daily life for a minimum of 3 months, but have the option to continue to wear devices for six months. Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Hearing Loss
What is being tested?: Receiver-in-canal hearing instrument
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteUnited States
Study dates: 1 Aug 2020to 31 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 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Mild to moderate sensorineural hearing loss
Adult

Who cannot join

Inability or unwillingness to wear study devices for extended period of time.

Trial locations and contacts

1 site in 1 country.

United States1 site

Phonak Audiology Research Center
Aurora, Illinois, 60504

Other trials in United States

About this study

Official title: A Study to Examine the Performance of a Hearing Aid Transducer During Typical, In-field Use

Conditions: Hearing Loss
Being tested: Receiver-in-canal hearing instrument
Medical subject headings: Hearing Loss

What participants receive

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

Receiver-in-canal hearing instrumentDevice
Receiver-in-canal hearing instrument

Study groups in NCT04787055
Study group	Role	What they receive
Receiver in the canal hearing instrument 3 month	Experimental	Group of subjects who will get the receiver in the canal hearing instrument and wear for period of three months. Receives: Device: Receiver-in-canal hearing instrument
Receiver in the canal hearing instrument 6 month	Experimental	Group of subjects who will get the receiver in the canal hearing instrument and wear for period of six months. Receives: Device: Receiver-in-canal hearing instrument

What is being measured

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

Subjective Satisfaction of Hearing Aid Performance in Noisy Environments
Subject rates how satisfied they are with performance of hearing aid while listening in noisy environments. Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied.
Measured: Three months after initial appointment
Subjective Satisfaction of Hearing Aid Performance in Noisy Environments
Subject rates how satisfied they are with performance of hearing aid while listening in noisy environments. Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied.
Measured: Six months after initial appointment
Subjective Satisfaction of Hearing Aid Performance While Listening to Streamed Media
Subject rates how satisfied they are with performance of hearing aid when listening to a streamed signal (i.e. music, video, etc.) Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied.
Measured: Three months after initial appointment
Subjective Satisfaction of Hearing Aid Performance While Listening to Streamed Media
Subject rates how satisfied they are with performance of hearing aid when listening to a streamed signal (i.e. music, video, etc.) Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied.
Measured: Six months after initial appointment

Timeline

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

1 Aug 202031 Dec 2021

First posted8 Mar 2021
Study start1 Aug 2020
Primary completion30 Sep 2021
Study completion31 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.
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: Other
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04787055
Sponsor's protocol ID: SRF-61
Status last verified: May 2022
First submitted: 28 Jan 2021
Last updated: 21 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

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

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All Hearing Loss trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Examine the Performance of a Hearing Aid Transducer During Typical, In-field Use
ClinicalTrials.gov ID: NCT04787055
Acronym / sponsor ID: SRF-61
Conditions: Hearing Loss
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Sonova AGIndustry (pharma, biotech, devices)
Study start: 1 Aug 2020 (actual)
Primary completion: 30 Sep 2021 (actual)
Study completion: 31 Dec 2021 (actual)
First posted: 8 Mar 2021 (actual)
Results: Posted 21 Apr 2023

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: Other
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Receiver in the canal hearing instrument 3 month	Experimental	Device: Receiver-in-canal hearing instrumentGroup of subjects who will get the receiver in the canal hearing instrument and wear for period of three months.
Receiver in the canal hearing instrument 6 month	Experimental	Device: Receiver-in-canal hearing instrumentGroup of subjects who will get the receiver in the canal hearing instrument and wear for period of six months.

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Mild to moderate sensorineural hearing loss
Adult

Key exclusion criteria (1 listed)

Inability or unwillingness to wear study devices for extended period of time.

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
Receiver-in-canal hearing instrumentReceiver-in-canal hearing instrument	Device	Receiver in the canal hearing instrument 3 month, Receiver in the canal hearing instrument 6 month

Primary outcome

Subjective Satisfaction of Hearing Aid Performance in Noisy Environments
Time frame: Three months after initial appointment
Subject rates how satisfied they are with performance of hearing aid while listening in noisy environments. Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied.
Subjective Satisfaction of Hearing Aid Performance in Noisy Environments
Time frame: Six months after initial appointment
Subject rates how satisfied they are with performance of hearing aid while listening in noisy environments. Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied.
Subjective Satisfaction of Hearing Aid Performance While Listening to Streamed Media
Time frame: Three months after initial appointment
Subject rates how satisfied they are with performance of hearing aid when listening to a streamed signal (i.e. music, video, etc.) Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied.
Subjective Satisfaction of Hearing Aid Performance While Listening to Streamed Media
Time frame: Six months after initial appointment
Subject rates how satisfied they are with performance of hearing aid when listening to a streamed signal (i.e. music, video, etc.) Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied.

Results and safety

Results posted to the registry on 21 Apr 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
Receiver in the Canal Hearing Instrument 3 Month	18	15
Receiver in the Canal Hearing Instrument 6 Month	17	11

Primary outcome: Subjective Satisfaction of Hearing Aid Performance in Noisy Environments

Time frame: Three months after initial appointment. Mean (Full Range). Unit: score on a scale

Measure	Receiver in the Canal Hearing Instrument 3 Month n = 15
Value	3.86 (2 to 5)

Population analysed: Participants who answered the question "How satisfied are you with the performance of the hearing aids in noisy environments?" after 3 months of wearing devices.

Primary outcome: Subjective Satisfaction of Hearing Aid Performance in Noisy Environments

Time frame: Six months after initial appointment. Mean (Full Range). Unit: score on a scale

Measure	Receiver in the Canal Hearing Instrument 6 Month n = 11
Value	2.73 (2 to 5)

Population analysed: Participants who wore device for six months and answered the question "How satisfied are you with the performance of the hearing aids in noisy environments?" at the end of the six months.

Primary outcome: Subjective Satisfaction of Hearing Aid Performance While Listening to Streamed Media

Time frame: Three months after initial appointment. Mean (Full Range). Unit: score on a scale

Measure	Receiver in the Canal Hearing Instrument 3 Month n = 15
Value	4.67 (2 to 5)

Population analysed: Participants who wore devices for three months and who answered the question at the end of the 3 months "How satisfied were you with the performance of the hearing aid when streaming?"

Primary outcome: Subjective Satisfaction of Hearing Aid Performance While Listening to Streamed Media

Time frame: Six months after initial appointment. Mean (Full Range). Unit: score on a scale

Measure	Receiver in the Canal Hearing Instrument 6 Months n = 11
Value	4.36 (4 to 5)

Population analysed: Participants who wore devices for 6 months and who answered the question at the end of the 6 months "How satisfied were you with the performance of the hearing aid when streaming?"

Adverse events

Time frame: Three months for participants who were in the group assigned devices for three months, and six months for the participants who were in group assigned devices for six months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Receiver in the Canal Hearing Instrument 3 Month	0 of 18 (0%)	0 of 18 (0%)	0 of 18
Receiver in the Canal Hearing Instrument 6 Month	1 of 17 (5.9%)	0 of 17 (0%)	1 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hearing Loss

RecruitingObservational study
Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
Vestibular Dysfunction, Hearing Loss
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
Not yet recruiting
Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss
Hearing Loss, Bilateral
RecruitingObservational study
Natural History of Autosomal Dominant Hearing Loss
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RecruitingObservational study
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
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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 Receiver-in-canal hearing instrument 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 1 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 21 Apr 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 21 Apr 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?

Subjective Satisfaction of Hearing Aid Performance in Noisy Environments (time frame: Three months after initial appointment). The study lists 4 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 NCT04787055.

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 21 Apr 2023.