Hearing Loss, SensorineuralNCT05956808
Phonak Behind-The-Ear Quality Evaluation
A study testing Phonak Naida BTE hearing aid and Phonak Naida legacy BTE hearing aid in people with Hearing Loss, Sensorineural, run by Sonova AG at 1 site in United States.
Trial summary
Subjective listening effort and objective speech intelligibility will be evaluated with a new generation of a Phonak BTE (Behind-The-Ear) hearing aid. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Sensorineural
- What is being tested?
- Phonak Naida BTE hearing aid and Phonak Naida legacy BTE hearing aid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2023to 16 Aug 2023
- 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
- Severe to profound hearing loss (4 frequency Pure Tone Average 65-94 dB)
- 18+ years old
- Good written and spoken English language skills
- Able to fill in a questionnaire conscientiously
- Experienced hearing aid user
- Able to produce a reliable hearing test result
- Able to describe listening impressions/experiences and the use of the hearing aids
Who cannot join
- Not willing to test the hearing aids
- Has auricle deformities that prevents secure placement of the hearing aids
- Has limited mobility and is not able to attend the appointments
- Not willing to wear the hearing aids for at least 8 hours per day
- Known hypersensitivity or allergy with synthetic materials
- Self reports symptoms of vertigo, dizziness, fluctuating hearing loss
- Hints of psychological problems
- Suffers from acute tinnitus in either one or both ears (occurrence less than 3 months)
Trial locations and contacts
1 site in 1 country.
United States1 site
Phonak Audiology Research Center
Aurora, Illinois, 60504
About this study
Subjective listening effort and objective speech intelligibility will be evaluated with a new generation of a Phonak BTE (Behind-The-Ear) hearing aid.
Read the detailed description
Speech intelligibility performance will be measured with a new generation BTE hearing aid and compared to a legacy hearing aid in adults with severe to profound hearing loss.
- Conditions
- Hearing Loss, Sensorineural
- Being tested
- Phonak Naida BTE hearing aid, Phonak Naida legacy BTE 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.
Phonak Naida BTE hearing aidDevice
Newest generation of ultra-power Phonak BTE hearing aids
Phonak Naida legacy BTE hearing aidDevice
Previous model/generation of the Naida BTE hearing aid
| Study group | Role | What they receive |
|---|---|---|
| New BTE hearing aid first, then legacy BTE hearing aid | Experimental | All participants who complete speech intelligibility testing and subjective listening effort ratings with both devices, first with the new hearing aid, and then with the legacy hearing aid. Receives: Device: Phonak Naida BTE hearing aid; Device: Phonak Naida legacy BTE hearing aid |
| Legacy BTE hearing aid first, then new BTE hearing aid | Experimental | All participants who complete speech intelligibility testing and subjective listening effort ratings with both devices, first with the new hearing aid, and then with the legacy hearing aid. Receives: Device: Phonak Naida BTE hearing aid; Device: Phonak Naida legacy BTE hearing aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech in Noise Test
Sentences are presented to either the left or right side of the participant's head through a speaker that is 1 meter away. Background noise is presented through the remaining seven speakers that are arranged in a circular pattern around the participant. The sentences are presented at varying levels which may be both louder and softer than the fixed level of noise. The SNR50 is the Signal to Noise Ratio (SNR) at which the participant can repeat 50% of the words correctly. For example, an SNR50 of +3 means that the participant repeated 50% of the words back correctly when the sentences were presented at a level that was 3 dB louder than the noise. Lower SNR50 scores indicate better performance.
Measured: Day 14 of the study
Subjective measure of listening effort
A rating scale will be given to the participants following the Speech in Noise Test in which they will rate their perceived listening effort during the test.
Measured: Day 14 of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start17 Jul 2023
- Primary completion16 Aug 2023
- Study completion16 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- This investigation model is a cross-over design, randomized, and is single-blinded.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonova AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956808
- Sponsor's protocol ID
- SRF-12872
- Status last verified
- Aug 2023
- First submitted
- 14 Jul 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No individual participant data will be shared outside of Sonova research departments.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phonak Behind-The-Ear Quality Evaluation
- ClinicalTrials.gov ID
- NCT05956808
- Acronym / sponsor ID
- SRF-12872
- Conditions
- Hearing Loss, Sensorineural
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 16 Aug 2023 (actual)
- Study completion
- 16 Aug 2023 (actual)
- First posted
- 21 Jul 2023 (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.
Subjective listening effort and objective speech intelligibility will be evaluated with a new generation of a Phonak BTE (Behind-The-Ear) hearing aid.
Detailed description
Speech intelligibility performance will be measured with a new generation BTE hearing aid and compared to a legacy hearing aid in adults with severe to profound hearing loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This investigation model is a cross-over design, randomized, and is single-blinded.
| Arm | Type | Receives |
|---|---|---|
| New BTE hearing aid first, then legacy BTE hearing aid | Experimental | Device: Phonak Naida BTE hearing aid, Device: Phonak Naida legacy BTE hearing aidAll participants who complete speech intelligibility testing and subjective listening effort ratings with both devices, first with the new hearing aid, and then with the legacy hearing aid. |
| Legacy BTE hearing aid first, then new BTE hearing aid | Experimental | Device: Phonak Naida BTE hearing aid, Device: Phonak Naida legacy BTE hearing aidAll participants who complete speech intelligibility testing and subjective listening effort ratings with both devices, first with the new hearing aid, and then with the legacy hearing aid. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Severe to profound hearing loss (4 frequency Pure Tone Average 65-94 dB)
- 18+ years old
- Good written and spoken English language skills
- Able to fill in a questionnaire conscientiously
- Experienced hearing aid user
Key exclusion criteria (8 listed)
- Not willing to test the hearing aids
- Has auricle deformities that prevents secure placement of the hearing aids
- Has limited mobility and is not able to attend the appointments
- Not willing to wear the hearing aids for at least 8 hours per day
- Known hypersensitivity or allergy with synthetic materials
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 |
|---|---|---|
| Phonak Naida BTE hearing aidNewest generation of ultra-power Phonak BTE hearing aids | Device | Legacy BTE hearing aid first, then new BTE hearing aid, New BTE hearing aid first, then legacy BTE hearing aid |
| Phonak Naida legacy BTE hearing aidPrevious model/generation of the Naida BTE hearing aid | Device | Legacy BTE hearing aid first, then new BTE hearing aid, New BTE hearing aid first, then legacy BTE hearing aid |
Primary outcome
Speech in Noise Test
Time frame: Day 14 of the study
Sentences are presented to either the left or right side of the participant's head through a speaker that is 1 meter away. Background noise is presented through the remaining seven speakers that are arranged in a circular pattern around the participant. The sentences are presented at varying levels which may be both louder and softer than the fixed level of noise. The SNR50 is the Signal to Noise Ratio (SNR) at which the participant can repeat 50% of the words correctly. For example, an SNR50 of +3 means that the participant repeated 50% of the words back correctly when the sentences were presented at a level that was 3 dB louder than the noise. Lower SNR50 scores indicate better performance.
Subjective measure of listening effort
Time frame: Day 14 of the study
A rating scale will be given to the participants following the Speech in Noise Test in which they will rate their perceived listening effort during the test.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Individual participant dataSharing planned: No. No individual participant data will be shared outside of Sonova research departments.
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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 Phonak Naida BTE hearing aid and Phonak Naida legacy BTE hearing aid in people with Hearing Loss, Sensorineural, 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 7 inclusion and 8 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 21 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in Noise Test (time frame: Day 14 of the study). 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?
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 21 Aug 2023.