Sensorineural Hearing LossNCT06746038
Evaluation of Extended Wear Hearing Aid for Mild Hearing Loss
A study testing Extended Wear Hearing Aid in people with Sensorineural Hearing Loss, run by Sonova AG at 1 site in United States.
Trial summary
This study will assess the benefit of extended wear hearing aids for subjective listening effort, compared to the unaided condition, in adults with mild sensorineural hearing loss. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sensorineural Hearing Loss
- What is being tested?
- Extended Wear Hearing Aid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2025to 15 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets requirements outlined on Lyric Candidacy Form
- Current Lyric hearing instrument user
- 18 years of age or older at time of enrollment in the study
- Mild sensorineural hearing loss as defined by WHO, 4 frequency PTA of 20-34 dB HL, in the better hearing ear
- Good understanding (read/write/speak) of the English language
- Willingness to comply with all study requirements
Who cannot join
- Does not meet requirements outlined on Lyric Candidacy Form (see Chapter 9 of the TMF/ISF for SRF-469)
- Difficulty understanding/reading instructions when corrected for vision loss
- Impairments that would restrict participation in any of the evaluations
- Ear health conditions present at baseline that prevent immediate device replacement
- Conditions that would indicate the need for medical referral prior to hearing aid fitting, according to clinic's standard protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
The Woodlands Hearing Center
Shenandoah, Texas, 77384
About this study
This study will assess the benefit of extended wear hearing aids for subjective listening effort, compared to the unaided condition, in adults with mild sensorineural hearing loss.
Read the detailed description
This study will assess the benefit of extended wear hearing aids for subjective listening effort, compared to the unaided condition, in adults with mild sensorineural hearing loss. Participants will be experienced hearing aid users who have previously worn or currently wear extended wear hearing devices. The primary objective will be to assess subjective listening effort, compared to unaided.
- Conditions
- Sensorineural Hearing Loss
- Being tested
- Extended Wear Hearing Aid
- Keywords
- extended wear hearing aid
- 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.
Extended Wear Hearing AidDevice
Also called Lyric4
Extended wear hearing aid means that the device is worn 24 hours per day, 7 days a week for months at a time. However, this study will only fit devices on participants for one testing session lasting 2 hours.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Participants who are fit with study Lyric devices and tested on speech intelligibility and effort using two different fitting algorithms Receives: Device: Extended Wear Hearing Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
NASA Task Load Index (NASA-TLX)
A raw score on six demensions (mental demand, physical demand, temporal demand, frustration, effort, performance) on a scale from 1 (low/good) to 20 (high/poor). A higher score indicates higher levels of subjective effort.
Measured: Day 1 of 1 day study
Secondary outcomes (1)
AZBio Speech in noise testing
The percentage of words correctly repeated by the participant when listening to sentences played from a front speaker at a certain dB level, while background noise is presented simultaneously from four corner speakers. A higher percentage indicates better speech understanding in noise.
Measured: Day 1 of 1 day study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start15 Jan 2025 (estimated)
- Primary completion15 Mar 2025 (estimated)
- Study completion15 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensorineural 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
- Model description
- A single group of participants will be fit with the extended wear hearing devices and will be tested in both the aided and unaided conditions in various tasks. Conditions will be counterbalanced and all participants will experience the same conditions. Conditions will include unaided, aided with pre-calculation A, and aided with pre-calculation B.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sonova AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Woodlands Hearing Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746038
- Sponsor's protocol ID
- SRF-469
- Status last verified
- Sep 2024
- First submitted
- 18 Dec 2024
- Last updated
- 24 Dec 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 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Extended Wear Hearing Aid for Mild Hearing Loss
- ClinicalTrials.gov ID
- NCT06746038
- Acronym / sponsor ID
- SRF-469
- Conditions
- Sensorineural Hearing Loss
- Keywords
- extended wear hearing aid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Collaborators
- The Woodlands Hearing Center
- Study start
- 15 Jan 2025 (estimated)
- Primary completion
- 15 Mar 2025 (estimated)
- Study completion
- 15 Mar 2025 (estimated)
- First posted
- 24 Dec 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.
This study will assess the benefit of extended wear hearing aids for subjective listening effort, compared to the unaided condition, in adults with mild sensorineural hearing loss.
Detailed description
This study will assess the benefit of extended wear hearing aids for subjective listening effort, compared to the unaided condition, in adults with mild sensorineural hearing loss. Participants will be experienced hearing aid users who have previously worn or currently wear extended wear hearing devices. The primary objective will be to assess subjective listening effort, compared to unaided.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single group of participants will be fit with the extended wear hearing devices and will be tested in both the aided and unaided conditions in various tasks. Conditions will be counterbalanced and all participants will experience the same conditions. Conditions will include unaided, aided with pre-calculation A, and aided with pre-calculation B.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: Extended Wear Hearing AidParticipants who are fit with study Lyric devices and tested on speech intelligibility and effort using two different fitting algorithms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Meets requirements outlined on Lyric Candidacy Form
- Current Lyric hearing instrument user
- 18 years of age or older at time of enrollment in the study
- Mild sensorineural hearing loss as defined by WHO, 4 frequency PTA of 20-34 dB HL, in the better hearing ear
- Good understanding (read/write/speak) of the English language
Key exclusion criteria (5 listed)
- Does not meet requirements outlined on Lyric Candidacy Form (see Chapter 9 of the TMF/ISF for SRF-469)
- Difficulty understanding/reading instructions when corrected for vision loss
- Impairments that would restrict participation in any of the evaluations
- Ear health conditions present at baseline that prevent immediate device replacement
- Conditions that would indicate the need for medical referral prior to hearing aid fitting, according to clinic's standard protocol
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 |
|---|---|---|
| Extended Wear Hearing AidAlso: Lyric4Extended wear hearing aid means that the device is worn 24 hours per day, 7 days a week for months at a time. However, this study will only fit devices on participants for one testing session lasting 2 hours. | Device | Experimental Group |
Primary outcome
NASA Task Load Index (NASA-TLX)
Time frame: Day 1 of 1 day study
A raw score on six demensions (mental demand, physical demand, temporal demand, frustration, effort, performance) on a scale from 1 (low/good) to 20 (high/poor). A higher score indicates higher levels of subjective effort.
1 secondary outcome
AZBio Speech in noise testing
Time frame: Day 1 of 1 day study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Sensorineural Hearing Loss
RecruitingObservational study
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
Cochlear Hearing Loss
RecruitingObservational study
Retrospectively Investigating Longitudinal Outcomes in MED-EL SONATA 2 Cochlear Implant Recipients.
Cochlear Implantation, Sensorineural Hearing Loss
Enrolling by invitationObservational study
Post-Market Registry Study for Vibrant Hearing Solutions
Conductive Hearing Loss, Mixed Hearing Loss
Enrolling by invitationObservational study
Long Term Follow-up Study of AAVAnc80-hOTOF Gene Therapy
Otoferlin Gene-mediated Hearing Loss
Active, not recruiting
Performance of a Remote Microphone Compared to Hearing Aids Alone
Hearing Loss, Bilateral Sensorineural
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extended Wear Hearing Aid in people with Sensorineural 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 6 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: status not confirmed, as of the sponsor's last update on 24 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Study Manager (630-821-5000, PARCResearch@phonak.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NASA Task Load Index (NASA-TLX) (time frame: Day 1 of 1 day study). 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 24 Dec 2024.