Hearing LossNCT06710236
Evaluation of Investigational Hearing Instrument Features
A study testing Hearing instrument in people with Hearing Loss, run by Sonova AG at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn how hearing instruments perform in varying environmental settings in adults with hearing loss. The main questions it aims to answer are: How do varying versions of hearing instrument features perform based on exposure to different environments? What is the hearing instrument… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Hearing instrument
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2024to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult, age 18 - 95 years
- N4 hearing loss
- Experienced hearing aid user
- English fluency
- Cognitively able to complete complex listening tasks
Who cannot join
- Normal hearing, or hearing loss outside the specified range
- No hearing aid experience
- Unable to speak, read, or write English fluently
- Cognitive impairment
- Any other condition or situation that impacts eligibility to participate in or complete study tasks, at the discretion of the investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Phonak Audiology Research Center
Aurora, Illinois, 60504
Study Coordinator, 800-679-4871, sv.clinical@sonova.com
About this study
The goal of this clinical trial is to learn how hearing instruments perform in varying environmental settings in adults with hearing loss. The main questions it aims to answer are:
How do varying versions of hearing instrument features perform based on exposure to different environments? What is the hearing instrument user preference between varying versions of hearing instrument features?
Participants will be fit with hearing instruments in the lab, and asked to wear them for the duration of the study period in their home environment. Participants will be asked to answer questionnaires throughout the study period.
- Conditions
- Hearing Loss
- Being tested
- 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.
Hearing instrumentDevice
Conventional, daily wear hearing instruments will be used in this study.
| Study group | Role | What they receive |
|---|---|---|
| Hearing Aid Users | Experimental | Participants will wear hearing instruments for the duration of the study period. They will be asked to complete questionnaires about their environment and experience. Receives: Device: Hearing instrument |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing instrument feature performance
Accuracy of hearing instrument feature performance based on environmental sampling and subjective reporting
Measured: From enrollment to the completion of data collection, approximately 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start18 Nov 2024 (estimated)
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sonova AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06710236
- Sponsor's protocol ID
- SRF-26463
- Status last verified
- Nov 2024
- First submitted
- 25 Nov 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Investigational Hearing Instrument Features
- ClinicalTrials.gov ID
- NCT06710236
- Acronym / sponsor ID
- SRF-26463
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2024 (estimated)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 29 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn how hearing instruments perform in varying environmental settings in adults with hearing loss. The main questions it aims to answer are:
How do varying versions of hearing instrument features perform based on exposure to different environments? What is the hearing instrument user preference between varying versions of hearing instrument features?
Participants will be fit with hearing instruments in the lab, and asked to wear them for the duration of the study period in their home environment. Participants will be asked to answer questionnaires throughout the study period.
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 Users | Experimental | Device: Hearing instrumentParticipants will wear hearing instruments for the duration of the study period. They will be asked to complete questionnaires about their environment and experience. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult, age 18 - 95 years
- N4 hearing loss
- Experienced hearing aid user
- English fluency
- Cognitively able to complete complex listening tasks
Key exclusion criteria (5 listed)
- Normal hearing, or hearing loss outside the specified range
- No hearing aid experience
- Unable to speak, read, or write English fluently
- Cognitive impairment
- Any other condition or situation that impacts eligibility to participate in or complete study tasks, at the discretion of the investigator
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 instrumentConventional, daily wear hearing instruments will be used in this study. | Device | Hearing Aid Users |
Primary outcome
Hearing instrument feature performance
Time frame: From enrollment to the completion of data collection, approximately 6 weeks
Accuracy of hearing instrument feature performance based on environmental sampling and subjective reporting
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 29 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Audiologist (800-679-4871, sv.clinical@sonova.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hearing instrument feature performance (time frame: From enrollment to the completion of data collection, approximately 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Nov 2024.