Hearing Loss, SensorineuralNCT05180630

Sound Quality Comparisons With Different Hearing Aid Couplings and Venting Systems

A study testing Audeo P90 hearing aid with custom earmolds using dynamic venting, Audeo P90 hearing aid with Open domes and Audeo P90 hearing aid with Vented domes 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

Participants will be comparing the sound quality of their own voice and the sound quality of streamed music using universal couplings and a custom earmold with a dynamic vent. Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Hearing Loss, Sensorineural
What is being tested?: Audeo P90 hearing aid with custom earmolds using dynamic venting, Audeo P90 hearing aid with Open domes and Audeo P90 hearing aid with Vented domes
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 1 siteUnited States
Study dates: 1 Oct 2021to 22 Apr 2022
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 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Mild to severe bilateral sensorineural hearing loss
hearing must be symmetrical below 500 Hz
must live within 30 miles of Aurora IL

Who cannot join

Trial locations and contacts

1 site in 1 country.

United States1 site

Sonova US
Aurora, Illinois, 60504

Other trials in United States

About this study

Official title: Sound Quality and Occlusion Comparisons With Different Hearing Aid Couplings and Venting Systems

Participants will be comparing the sound quality of their own voice and the sound quality of streamed music using universal couplings and a custom earmold with a dynamic vent.

Conditions: Hearing Loss, Sensorineural
Being tested: Audeo P90 hearing aid with custom earmolds using dynamic venting, Audeo P90 hearing aid with Open domes, Audeo P90 hearing aid with Vented domes
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.

Audeo P90 hearing aid with custom earmolds using dynamic ventingDevice
Audeo P90 hearing aids coupled to custom earmolds that use dynamic venting.
Audeo P90 hearing aid with Open domesDevice
Audeo P90 hearing aid coupled with non-custom, manufacturer open domes
Audeo P90 hearing aid with Vented domesDevice
Audeo P90 hearing aid coupled with non-custom, manufacturer vented domes

Study groups in NCT05180630
Study group	Role	What they receive
Custom earmolds, then Open domes, then Vented domes	Experimental	Participants first fit with Audeo 90P hearing aids and custom earmolds with dynamic venting, then fit with the same hearing aids using open domes, then fit with the same hearing aids using vented domes. Receives: Device: Audeo P90 hearing aid with custom earmolds using dynamic venting; Device: Audeo P90 hearing aid with Open domes; Device: Audeo P90 hearing aid with Vented domes
Open domes, then Vented domes, then Custom earmolds	Experimental	Participants first fit with Audeo 90P hearing aids and open domes, then fit with the same hearing aids using vented domes, then fit with the same hearing aids using custom earmolds with dynamic venting. Receives: Device: Audeo P90 hearing aid with custom earmolds using dynamic venting; Device: Audeo P90 hearing aid with Open domes; Device: Audeo P90 hearing aid with Vented domes
Vented domes, then Custom earmolds, then Open domes	Experimental	Participants first fit with Audeo 90P hearing aids and vented domes, then fit with the same hearing aids using custom earmolds with dynamic venting, then fit with the same hearing aids using open domes. Receives: Device: Audeo P90 hearing aid with custom earmolds using dynamic venting; Device: Audeo P90 hearing aid with Open domes; Device: Audeo P90 hearing aid with Vented domes

What is being measured

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

Sound Quality of Streamed Music Rating Scale
subjective rating on scale from 0 (worst) to 100 (best) for sound quality of streamed signal
Measured: 1 day
Own Voice Sound Quality Rating Scale
subjective rating on a scale from 0 (worst) to 100 (best) for sound quality of participant's own voice quality.
Measured: 1 day

Timeline

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

1 Oct 202122 Apr 2022

First posted6 Jan 2022
Study start1 Oct 2021
Primary completion28 Feb 2022
Study completion22 Apr 2022

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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05180630
Sponsor's protocol ID: SRF-465
Status last verified: Jun 2023
First submitted: 25 Nov 2021
Last updated: 28 Jun 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

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Retrospectively Investigating Longitudinal Outcomes in MED-EL SONATA 2 Cochlear Implant Recipients.
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Enrolling by invitationObservational study
Long Term Follow-up Study of AAVAnc80-hOTOF Gene Therapy
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Enrolling by invitationObservational study
Post-Market Registry Study for Vibrant Hearing Solutions
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Active, not recruiting
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All Hearing Loss, Sensorineural trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sound Quality and Occlusion Comparisons With Different Hearing Aid Couplings and Venting Systems
ClinicalTrials.gov ID: NCT05180630
Acronym / sponsor ID: SRF-465
Conditions: Hearing Loss, Sensorineural
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: Sonova AGIndustry (pharma, biotech, devices)
Study start: 1 Oct 2021 (actual)
Primary completion: 28 Feb 2022 (actual)
Study completion: 22 Apr 2022 (actual)
First posted: 6 Jan 2022 (actual)
Results: Posted 28 Jun 2023

Clinical summary

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

Participants will be comparing the sound quality of their own voice and the sound quality of streamed music using universal couplings and a custom earmold with a dynamic vent.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Custom earmolds, then Open domes, then Vented domes	Experimental	Device: Audeo P90 hearing aid with custom earmolds using dynamic venting, Device: Audeo P90 hearing aid with Open domes, Device: Audeo P90 hearing aid with Vented domesParticipants first fit with Audeo 90P hearing aids and custom earmolds with dynamic venting, then fit with the same hearing aids using open domes, then fit with the same hearing aids using vented domes.
Open domes, then Vented domes, then Custom earmolds	Experimental	Device: Audeo P90 hearing aid with custom earmolds using dynamic venting, Device: Audeo P90 hearing aid with Open domes, Device: Audeo P90 hearing aid with Vented domesParticipants first fit with Audeo 90P hearing aids and open domes, then fit with the same hearing aids using vented domes, then fit with the same hearing aids using custom earmolds with dynamic venting.
Vented domes, then Custom earmolds, then Open domes	Experimental	Device: Audeo P90 hearing aid with custom earmolds using dynamic venting, Device: Audeo P90 hearing aid with Open domes, Device: Audeo P90 hearing aid with Vented domesParticipants first fit with Audeo 90P hearing aids and vented domes, then fit with the same hearing aids using custom earmolds with dynamic venting, then fit with the same hearing aids using open domes.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Mild to severe bilateral sensorineural hearing loss
hearing must be symmetrical below 500 Hz
must live within 30 miles of Aurora IL

Key exclusion criteria (1 listed)

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
Audeo P90 hearing aid with custom earmolds using dynamic ventingAudeo P90 hearing aids coupled to custom earmolds that use dynamic venting.	Device	Custom earmolds, then Open domes, then Vented domes, Open domes, then Vented domes, then Custom earmolds, Vented domes, then Custom earmolds, then Open domes
Audeo P90 hearing aid with Open domesAudeo P90 hearing aid coupled with non-custom, manufacturer open domes	Device	Custom earmolds, then Open domes, then Vented domes, Open domes, then Vented domes, then Custom earmolds, Vented domes, then Custom earmolds, then Open domes
Audeo P90 hearing aid with Vented domesAudeo P90 hearing aid coupled with non-custom, manufacturer vented domes	Device	Custom earmolds, then Open domes, then Vented domes, Open domes, then Vented domes, then Custom earmolds, Vented domes, then Custom earmolds, then Open domes

Primary outcome

Sound Quality of Streamed Music Rating Scale
Time frame: 1 day
subjective rating on scale from 0 (worst) to 100 (best) for sound quality of streamed signal
Own Voice Sound Quality Rating Scale
Time frame: 1 day
subjective rating on a scale from 0 (worst) to 100 (best) for sound quality of participant's own voice quality.

Results and safety

Results posted to the registry on 28 Jun 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
Custom Earmolds, Then Open Domes, Then Vented Domes	6	6
Open Domes, Then Vented Domes, Then Custom Earmolds	6	6
Vented Domes, Then Custom Earmolds, Then Open Domes	5	2

Primary outcome: Sound Quality of Streamed Music Rating Scale

Time frame: 1 day. Mean (Full Range). Unit: score on a scale

Measure	Custom Earmolds, Then Open Domes, Then Vented Domes n = 6	Open Domes, Then Vented Domes, Then Custom Earmolds n = 6	Vented Domes, Then Custom Earmolds, Then Open Domes n = 2
Subjective sound quality rating of streamed music with custom earmolds	84 (75 to 100)	70 (25 to 100)	70 (60 to 80)
Subjective sound quality rating of streamed music using open domes	90 (80 to 100)	62.5 (25 to 100)	80 (70 to 90)
Subjective sound quality rating of streamed music using vented domes	94 (84 to 100)	81 (50 to 100)	90 (80 to 100)

Custom Earmolds, Then Open Domes, Then Vented Domes vs Open Domes, Then Vented Domes, Then Custom Earmolds vs Vented Domes, Then Custom Earmolds, Then Open Domes: p = 0.012, ANOVA

Population analysed: All participants who evaluated the sound quality of streamed music using all three coupling systems.

Primary outcome: Own Voice Sound Quality Rating Scale

Time frame: 1 day. Mean (Full Range). Unit: score on a scale

Measure	Custom Earmolds, Then Open Domes, Then Vented Domes n = 6	Open Domes, Then Vented Domes, Then Custom Earmolds n = 6	Vented Domes, Then Custom Earmolds, Then Open Domes n = 2
Subjective rating of own voice using custom earmolds with dynamic venting	69.2 (50 to 90)	75 (55 to 90)	40 (30 to 50)
Subjective rating of own voice sound quality using open domes	80 (63 to 98)	78 (50 to 100)	50 (25 to 75)
Subjective rating of own voice sound quality using vented domes	85 (75 to 100)	73 (40 to 100)	65 (55 to 75)

Custom Earmolds, Then Open Domes, Then Vented Domes vs Open Domes, Then Vented Domes, Then Custom Earmolds vs Vented Domes, Then Custom Earmolds, Then Open Domes: p = 0.154, ANOVA

Population analysed: All participants who rated sound quality of own voice using hearing aids with all three coupling systems.

Adverse events

Time frame: Two separate appointments, one day each, for a total of two non-consecutive days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Participants Who Received Intervention of Custom Earmolds With Dynamic Venting	0 of 14 (0%)	0 of 14 (0%)	0 of 14
Participants Who Received Intervention of Open Domes	0 of 14 (0%)	0 of 14 (0%)	0 of 14
Participants Who Received Intervention Vented Domes	0 of 17 (0%)	0 of 17 (0%)	0 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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 3 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 28 Jun 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 28 Jun 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?

Sound Quality of Streamed Music Rating Scale (time frame: 1 day). The study lists 2 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 NCT05180630.

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 28 Jun 2023.