Hearing Loss, SensorineuralNCT04839289

Hearing Aid Signal Processing Comparative Study

A study testing Receiver-in-canal hearing instrument; Manufacturer A and Receiver-in-canal hearing instrument; Manufacturer B in people with Hearing Loss, Sensorineural, 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

Who is it for?: Ages 18 to 100 yearsHealthy volunteers can take part
Conditions the study is for: Hearing Loss, Sensorineural
What is being tested?: Receiver-in-canal hearing instrument; Manufacturer A and Receiver-in-canal hearing instrument; Manufacturer B
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 1 siteUnited States
Study dates: 1 Jul 2021to 31 Aug 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 100 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Moderate to severe sensorineural hearing loss
Current hearing aid user

Who cannot join

Lack of willingness to wear study devices for approximately one month
Inability to travel to study appointments or to complete questionnaires.

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 Compare Patient Perceptions of Two Different Hearing Aid Signal Processing Philosophies

Participants will be fit with each of two hearing instruments in an ABA cross-over design. The study will consist of a total of three approximately 10-day home trials with the devices. Participants will be asked to provide qualitative feedback to investigators regarding the performance of and their preference for each hearing instrument.

Conditions: Hearing Loss, Sensorineural
Being tested: Receiver-in-canal hearing instrument; Manufacturer A, Receiver-in-canal hearing instrument; Manufacturer B
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.

Receiver-in-canal hearing instrument; Manufacturer ADevice
Commercially available receiver-in-canal hearing instrument from manufacturer A
Receiver-in-canal hearing instrument; Manufacturer BDevice
Commercially available receiver-in-canal hearing instrument from manufacturer B

Study groups in NCT04839289
Study group	Role	What they receive
A-B-A	Experimental	Participants will be fit with hearing instruments A and B in the following order: Hearing instrument A Hearing instrument B Hearing instrument A Receives: Device: Receiver-in-canal hearing instrument; Manufacturer A; Device: Receiver-in-canal hearing instrument; Manufacturer B
B-A-B	Experimental	Participants will be fit with hearing instruments A and B in the following order: Hearing instrument B Hearing instrument A Hearing instrument B Receives: Device: Receiver-in-canal hearing instrument; Manufacturer A; Device: Receiver-in-canal hearing instrument; Manufacturer B

What is being measured

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

Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for First Study Set Worn, i.e. Study Set A for Arm A-B-A and Study Set B for Arm B-A-B
Qualitative feedback questionnaire to gather feedback on particular areas of focus. Subjects will rate hearing performance and sound quality on a Likert scale with lowest number equivalent to worst performance or worst sound quality (1) and higher number equivalent to best performance or best sound quality (10).
Measured: End of home trial 1 (Day 10 of study)
Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for Second Study Set Worn, i.e. Study Set B for Arm A-B-A and Study Set A for Arm B-A-B
Qualitative feedback questionnaire to gather feedback on particular areas of focus. Subjects will rate hearing performance and sound quality on a Likert scale with lowest number equivalent to worst performance or worst sound quality (1) and higher number equivalent to best performance or best sound quality (10).
Measured: End of home trial 2 (20 days after study start)
Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for Third Study Set Worn, i.e. Study Set A for Arm A-B-A and Study Set B for Arm B-A-B
Qualitative feedback questionnaire to gather feedback on particular areas of focus. Subjects will rate hearing performance and sound quality on a Likert scale with lowest number equivalent to worst performance or worst sound quality (1) and higher number equivalent to best performance or best sound quality (10).
Measured: End of home trial 3 (30 days after study start)
Standard Validated Questionnaire Measuring Satisfaction of Hearing Aid Performance and Features for First Study Set Worn.
Measures satisfaction on various aspects of hearing aid use on a scale from 1 to 5, with 1 = Very unsatisfied to 5 = Very satisfied, and 3 = Neutral.
.
Measured: End of home trial 1 (Day 10 of study)
Standard Validated Questionnaire Measuring Satisfaction of Hearing Aid Performance and Features for Second Study Set Worn.
Measures satisfaction on various aspects of hearing aid use on a scale from 1 to 5, with 1 = Very unsatisfied to 5 = Very satisfied, and 3 = Neutral.
Measured: End of home trial 2 (Day 20 of study)
Standard Validated Questionnaire Measuring Satisfaction of Hearing Aid Performance and Features for Third Study Set Worn.
Measures satisfaction on various aspects of hearing aid use on a scale from 1 to 5, with 1 = Very unsatisfied to 5 = Very satisfied, and 3 = Neutral.
Measured: End of home trial 3 (Day 30 of study)

Timeline

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

1 Jul 202131 Aug 2021

First posted9 Apr 2021
Study start1 Jul 2021
Primary completion31 Aug 2021
Study completion31 Aug 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 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: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04839289
Sponsor's protocol ID: SRF-311
Status last verified: Jul 2021
First submitted: 25 Feb 2021
Last updated: 22 Mar 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, Sensorineural trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Compare Patient Perceptions of Two Different Hearing Aid Signal Processing Philosophies
ClinicalTrials.gov ID: NCT04839289
Acronym / sponsor ID: SRF-311
Conditions: Hearing Loss, Sensorineural
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Sonova AGIndustry (pharma, biotech, devices)
Study start: 1 Jul 2021 (actual)
Primary completion: 31 Aug 2021 (actual)
Study completion: 31 Aug 2021 (actual)
First posted: 9 Apr 2021 (actual)
Results: Posted 22 Mar 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
A-B-A	Experimental	Device: Receiver-in-canal hearing instrument; Manufacturer A, Device: Receiver-in-canal hearing instrument; Manufacturer BParticipants will be fit with hearing instruments A and B in the following order: Hearing instrument A Hearing instrument B Hearing instrument A
B-A-B	Experimental	Device: Receiver-in-canal hearing instrument; Manufacturer A, Device: Receiver-in-canal hearing instrument; Manufacturer BParticipants will be fit with hearing instruments A and B in the following order: Hearing instrument B Hearing instrument A Hearing instrument B

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Moderate to severe sensorineural hearing loss
Current hearing aid user

Key exclusion criteria (2 listed)

Lack of willingness to wear study devices for approximately one month
Inability to travel to study appointments or to complete questionnaires.

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 instrument; Manufacturer ACommercially available receiver-in-canal hearing instrument from manufacturer A	Device	A-B-A, B-A-B
Receiver-in-canal hearing instrument; Manufacturer BCommercially available receiver-in-canal hearing instrument from manufacturer B	Device	A-B-A, B-A-B

Primary outcome

Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for First Study Set Worn, i.e. Study Set A for Arm A-B-A and Study Set B for Arm B-A-B
Time frame: End of home trial 1 (Day 10 of study)
Qualitative feedback questionnaire to gather feedback on particular areas of focus. Subjects will rate hearing performance and sound quality on a Likert scale with lowest number equivalent to worst performance or worst sound quality (1) and higher number equivalent to best performance or best sound quality (10).
Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for Second Study Set Worn, i.e. Study Set B for Arm A-B-A and Study Set A for Arm B-A-B
Time frame: End of home trial 2 (20 days after study start)
Qualitative feedback questionnaire to gather feedback on particular areas of focus. Subjects will rate hearing performance and sound quality on a Likert scale with lowest number equivalent to worst performance or worst sound quality (1) and higher number equivalent to best performance or best sound quality (10).
Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for Third Study Set Worn, i.e. Study Set A for Arm A-B-A and Study Set B for Arm B-A-B
Time frame: End of home trial 3 (30 days after study start)
Qualitative feedback questionnaire to gather feedback on particular areas of focus. Subjects will rate hearing performance and sound quality on a Likert scale with lowest number equivalent to worst performance or worst sound quality (1) and higher number equivalent to best performance or best sound quality (10).
Standard Validated Questionnaire Measuring Satisfaction of Hearing Aid Performance and Features for First Study Set Worn.
Time frame: End of home trial 1 (Day 10 of study)
Measures satisfaction on various aspects of hearing aid use on a scale from 1 to 5, with 1 = Very unsatisfied to 5 = Very satisfied, and 3 = Neutral. .
Standard Validated Questionnaire Measuring Satisfaction of Hearing Aid Performance and Features for Second Study Set Worn.
Time frame: End of home trial 2 (Day 20 of study)
Measures satisfaction on various aspects of hearing aid use on a scale from 1 to 5, with 1 = Very unsatisfied to 5 = Very satisfied, and 3 = Neutral.
Standard Validated Questionnaire Measuring Satisfaction of Hearing Aid Performance and Features for Third Study Set Worn.
Time frame: End of home trial 3 (Day 30 of study)
Measures satisfaction on various aspects of hearing aid use on a scale from 1 to 5, with 1 = Very unsatisfied to 5 = Very satisfied, and 3 = Neutral.

Results and safety

Results posted to the registry on 22 Mar 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
A-B-A	18	17
B-A-B	9	9

Primary outcome: Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for First Study Set Worn, i.e. Study Set A for Arm A-B-A and Study Set B for Arm B-A-B

Time frame: End of home trial 1 (Day 10 of study). Mean (Standard Deviation). Unit: score on a scale

Measure	A-B-A n = 17	B-A-B n = 9
Value	7.16 (0.46)	7.12 (0.85)

Population analysed: Participants who were fit with first set of hearing aids for first home trial. For arm A-B-A, the outcomes will measure hearing aid A, and for arm B-A-B, the outcomes will measure hearing aid B

Primary outcome: Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for Second Study Set Worn, i.e. Study Set B for Arm A-B-A and Study Set A for Arm B-A-B

Time frame: End of home trial 2 (20 days after study start). Mean (Standard Deviation). Unit: score on a scale

Measure	A-B-A n = 17	B-A-B n = 9
Value	7.61 (0.42)	6.70 (0.98)

Population analysed: Participants who were fit with second set of hearing aids for second home trial. For arm A-B-A, the outcomes will measure hearing aid B, and for arm B-A-B, the outcomes will measure hearing aid A

Primary outcome: Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for Third Study Set Worn, i.e. Study Set A for Arm A-B-A and Study Set B for Arm B-A-B

Time frame: End of home trial 3 (30 days after study start). Mean (Standard Deviation). Unit: score on a scale

Measure	A-B-A n = 17	B-A-B n = 9
Value	7.28 (.51)	7.52 (0.95)

A-B-A: p >0.05, t-test, 2 sided
B-A-B: p <.0167, t-test, 2 sided

Population analysed: Participants who were fit with third set of hearing aids for third home trial. For arm A-B-A, the outcomes will measure hearing aid A, and for arm B-A-B, the outcomes will measure hearing aid B

Primary outcome: Standard Validated Questionnaire Measuring Satisfaction of Hearing Aid Performance and Features for First Study Set Worn.

Time frame: End of home trial 1 (Day 10 of study). Mean (Standard Deviation). Unit: score on a scale

Measure	A-B-A n = 17	B-A-B n = 9
Value	3.94 (0.59)	3.80 (.30)

Population analysed: Participants who were fit with first set of hearing aids for first home trial. For arm A-B-A, the outcomes will measure study set A, and for arm B-A-B, the outcomes will measure study set B.

Adverse events

Time frame: The time frame in which the participant was enrolled in the study which was up to 8 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Receiver-in-canal Hearing Instrument Manufacturer A	0 of 27 (0%)	0 of 27 (0%)	0 of 27
Receiver-in-canal Hearing Instrument Manufacturer B	0 of 27 (0%)	0 of 27 (0%)	0 of 27

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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?

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 22 Mar 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 22 Mar 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?

Standardized Validated Questionnaire Measuring Hearing Aid Sound Quality for First Study Set Worn, i.e. Study Set A for Arm A-B-A and Study Set B for Arm B-A-B (time frame: End of home trial 1 (Day 10 of study)). The study lists 6 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 NCT04839289.

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 22 Mar 2023.