Hearing LossNCT05072470
Benefits of Assistive Listening Device for Speech Intelligibility
A study testing Roger microphone and Phonak Audeo hearing aid in people with Hearing Loss, run by Sonova AG at 1 site in United States.
Trial summary
Speech intelligibility in noise will be evaluated in adults with moderate to moderate-severe sensorineural hearing loss, using an assistive listening device and hearing aid, and compared to speech intelligibility in noise using hearing aids alone. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Roger microphone and Phonak Audeo 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
- 18 Oct 2021to 13 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults age 18 or older with bilateral moderate to moderate severe sensorineural hearing loss, pure tone average must be between 40 and 69 dB HL (decibel Hearing Level)
- experienced hearing aid users
- symmetric hearing loss (no more than 15 dB difference between the ears at three contiguous frequencies)
- good written and spoken English language skills
- healthy outer ear as confirmed by otoscopy
Who cannot join
- contradictions to medical device noted upon otoscopy
- known hypersensitivity or allergy to materials of investigational device or comparator
- inability to produce reliable test results
- known psychological problems
- self reported symptoms of dizziness or vertigo
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Benefits of an Assistive Listening Device for Speech Intelligibility in Noise
Speech intelligibility in noise will be evaluated in adults with moderate to moderate-severe sensorineural hearing loss, using an assistive listening device and hearing aid, and compared to speech intelligibility in noise using hearing aids alone.
- Conditions
- Hearing Loss
- Being tested
- Roger microphone, Phonak Audeo hearing aid
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roger microphoneDevice
Commercially available transmitter microphone which sends distant speech signals to a receiver that is attached/embedded into hearing aids.
Phonak Audeo hearing aidDevice
Commercially available receiver-in-canal hearing aid
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Participants with bilateral moderate to severe sensorineural hearing loss Receives: Device: Roger microphone; Device: Phonak Audeo hearing aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech Intelligibility in Noise
The percent of correctly repeated words, when a list of 10 sentences is presented in noise. Ten sentences are presented at a certain loudness level while background noise is presented simultaneously at a specific loudness level. The number of words repeated correctly is calculated from the total number of words presented.
Measured: Day 1 of a one day study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start18 Oct 2021
- Primary completion13 Dec 2021
- Study completion13 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonova AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hearts for Hearing
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072470
- Sponsor's protocol ID
- SRF-70
- Status last verified
- Aug 2021
- First submitted
- 28 Sep 2021
- Last updated
- 13 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of an Assistive Listening Device for Speech Intelligibility in Noise
- ClinicalTrials.gov ID
- NCT05072470
- Acronym / sponsor ID
- SRF-70
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Collaborators
- Hearts for Hearing
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 13 Dec 2021 (actual)
- Study completion
- 13 Dec 2021 (actual)
- First posted
- 11 Oct 2021 (actual)
- Results
- Posted 2 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Speech intelligibility in noise will be evaluated in adults with moderate to moderate-severe sensorineural hearing loss, using an assistive listening device and hearing aid, and compared to speech intelligibility in noise using hearing aids alone.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Roger microphone, Device: Phonak Audeo hearing aidParticipants with bilateral moderate to severe sensorineural hearing loss |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- adults age 18 or older with bilateral moderate to moderate severe sensorineural hearing loss, pure tone average must be between 40 and 69 dB HL (decibel Hearing Level)
- experienced hearing aid users
- symmetric hearing loss (no more than 15 dB difference between the ears at three contiguous frequencies)
- good written and spoken English language skills
- healthy outer ear as confirmed by otoscopy
Key exclusion criteria (5 listed)
- contradictions to medical device noted upon otoscopy
- known hypersensitivity or allergy to materials of investigational device or comparator
- inability to produce reliable test results
- known psychological problems
- self reported symptoms of dizziness or vertigo
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 |
|---|---|---|
| Roger microphoneCommercially available transmitter microphone which sends distant speech signals to a receiver that is attached/embedded into hearing aids. | Device | Experimental |
| Phonak Audeo hearing aidCommercially available receiver-in-canal hearing aid | Device | Experimental |
Primary outcome
Speech Intelligibility in Noise
Time frame: Day 1 of a one day study
The percent of correctly repeated words, when a list of 10 sentences is presented in noise. Ten sentences are presented at a certain loudness level while background noise is presented simultaneously at a specific loudness level. The number of words repeated correctly is calculated from the total number of words presented.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 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?
A study testing Roger microphone and Phonak Audeo hearing aid 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: finished, as of the sponsor's last update on 13 Feb 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 2 Dec 2022). 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?
Speech Intelligibility in Noise (time frame: Day 1 of a one 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 13 Feb 2023.