Hearing LossNCT05376215
A Comparison of Hearing Aid Fitting Methods
A study testing Experimental hearing aid in people with Hearing Loss, run by Sonova AG at 1 site in United States.
Trial summary
This investigation will compare hearing aid fitting methods between self-fitting and clinician fitting approaches by using a standardized questionnaire to evaluate subjective hearing aid benefit. 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?
- Experimental hearing aid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2022to 8 Dec 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild to moderate bilateral hearing loss
- First time (new) hearing aid users or experienced hearing aid users
- Ability to use a smartphone
- Fluent in English; ability to read and write in English
- Willing and able to provide informed consent
Who cannot join
- Self reported ear-related pathology including otorrhea within 90 days, dizziness, sudden onset or worsening of hearing loss within 90 days, visible deformity of the ear, otalgia
- Unilateral hearing loss
- Chronic, severe tinnitus
Trial locations and contacts
1 site in 1 country.
About this study
This investigation will compare hearing aid fitting methods between self-fitting and clinician fitting approaches by using a standardized questionnaire to evaluate subjective hearing aid benefit.
Read the detailed description
Participants will be fit with hearing aids using two different fitting methods (fitting A and fitting B). The order of the fitting will be randomized such that half of the participants will start out with fitting A and half of the participants will start out with fitting B. All participants will undergo baseline speech testing and answer a questionnaire about their experiences in daily life without hearing aids. All participants will use devices for a period of 1-2 weeks in their daily lives. After this first home trial, participants will return to the clinic where they will answer questionnaires regarding their experience with the devices. They will also perform aided speech testing. They will then be given devices with the second fitting method and will wear devices for a period of 1-2 weeks in their daily lives. Following the second home trial, all participants will return to the clinic to answer the same questionnaire that was given after home trial #1, and complete aided speech testing. The results for each of the two fitting methods will be analyzed.
- Conditions
- Hearing Loss
- Being tested
- Experimental 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.
Experimental hearing aidDevice
This hearing aid is a receiver-in-canal style hearing aid which can be programmed and adjusted by proprietary software and by use with a mobile application.
| Study group | Role | What they receive |
|---|---|---|
| Fitting method A first, then fitting method B | Active comparator | Participants will be fit with a set of hearing devices that are programmed to fitting method A first. This fitting method will use specific programming parameters and software to determine the most appropriate fitting algorithm.
Following a home trial with fitting method A, participants will then be fit with a set of hearing devices that are programmed to fitting method B. This fitting method will use a different set of programming parameters and software to determine the most appropriate algorithm. Receives: Device: Experimental hearing aid |
| Fitting method B first, then fitting method A | Experimental | Participants will be fit with a set of hearing aids that are programmed using fitting method B. This fitting method will use a different set of programming parameters and software to determine the most appropriate algorithm.
Following a home trial with fitting method B, participants will then be fit with a set of hearing devices that are programmed to fitting method A. This fitting method will use specific programming parameters and software to determine the most appropriate fitting algorithm. Receives: Device: Experimental hearing aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abbreviated Profile of Hearing Aid Benefit (APHAB)
A validated questionnaire that assesses the subjective benefit of hearing aids in daily life. Participants rate their difficulty hearing in different situations, going from Always (99%), Almost Always (87%), Generally (75%), Half the time (50%), Occasionally (25%), Seldom (12%) or Never (1%). For example, the participant may choose "Always" to the statement "When I am having a quiet conversation with a friend, I have difficulty understanding". The questions are categorized into 4 different sub-scales: Ease of Communication (EC), Background Noise (BN), Reverberation (RV), and Aversiveness. The global score is calculated by taking the average of three of the subscales: EC, BN, and RV. The scores can range from 1% to 99%. Global Benefit is calculated by subtracting the aided global score from the unaided global score. The mean global benefit is calculated for each fitting method, and a higher benefit score is better. Result reported is the global benefit score for each fitting method.
Measured: Day 1 (unaided testing), Day 14(aided testing for first fitting method) and Day 28 (aided testing for second fitting method) of study
Secondary outcomes (1)
Speech Perception in Noise, Expressed in Decibel (dB) Signal to Noise Ratio (SNR) Loss
Objective speech in noise testing calculates the level in which speech stimuli needs to be louder than background noise for the participant to correctly repeat back 50% of key words. A lower score/dB level is better. For example, a score of 2 dB means that the speech needs to be louder than the background noise by 2 dB in order for the individual to correctly repeat 50% of the words. However, a score of 10 dB means that the speech needs to be 10 dB louder than the background noise for the individual to correctly repeat 50% of the words. This test is done in the unaided condition, as well as with both aided conditions (fitting method A and fitting method B) and the benefit score for each fitting method is determined by subtracting the aided dB SNR score from the unaided dB SNR score. A higher benefit score is better.
Measured: Day 1 (unaided/baseline testing) of study, day 14 (aided testing with first fitting method) and day 28 (aided testing with second fitting method) of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start17 Aug 2022
- Primary completion8 Dec 2022
- Study completion8 Dec 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 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
- Randomised
- Intervention model
- Crossover
- Model description
- This study is a prospective, repeated measures, within-subject, cross over design. Subjects will be assigned in random order to the two fitting methods. Subjects will be blinded as to which fitting method they are using during the home trials.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonova AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of South Florida
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05376215
- Sponsor's protocol ID
- SRF-1236
- Status last verified
- Aug 2023
- First submitted
- 11 May 2022
- Last updated
- 1 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Hearing Aid Fitting Methods
- ClinicalTrials.gov ID
- NCT05376215
- Acronym / sponsor ID
- SRF-1236
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Collaborators
- University of South Florida
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- 8 Dec 2022 (actual)
- Study completion
- 8 Dec 2022 (actual)
- First posted
- 17 May 2022 (actual)
- Results
- Posted 1 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This investigation will compare hearing aid fitting methods between self-fitting and clinician fitting approaches by using a standardized questionnaire to evaluate subjective hearing aid benefit.
Detailed description
Participants will be fit with hearing aids using two different fitting methods (fitting A and fitting B). The order of the fitting will be randomized such that half of the participants will start out with fitting A and half of the participants will start out with fitting B. All participants will undergo baseline speech testing and answer a questionnaire about their experiences in daily life without hearing aids. All participants will use devices for a period of 1-2 weeks in their daily lives. After this first home trial, participants will return to the clinic where they will answer questionnaires regarding their experience with the devices. They will also perform aided speech testing. They will then be given devices with the second fitting method and will wear devices for a period of 1-2 weeks in their daily lives. Following the second home trial, all participants will return to the clinic to answer the same questionnaire that was given after home trial #1, and complete aided speech testing. The results for each of the two fitting methods will be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a prospective, repeated measures, within-subject, cross over design. Subjects will be assigned in random order to the two fitting methods. Subjects will be blinded as to which fitting method they are using during the home trials.
| Arm | Type | Receives |
|---|---|---|
| Fitting method A first, then fitting method B | Active comparator | Device: Experimental hearing aidParticipants will be fit with a set of hearing devices that are programmed to fitting method A first. This fitting method will use specific programming parameters and software to determine the most appropriate fitting algorithm. Following a home trial with fitting method A, participants will then be fit with a set of hearing devices that are programmed to fitting method B. This fitting method will use a different set of programming parameters and software to determine the most appropriate algorithm. |
| Fitting method B first, then fitting method A | Experimental | Device: Experimental hearing aidParticipants will be fit with a set of hearing aids that are programmed using fitting method B. This fitting method will use a different set of programming parameters and software to determine the most appropriate algorithm. Following a home trial with fitting method B, participants will then be fit with a set of hearing devices that are programmed to fitting method A. This fitting method will use specific programming parameters and software to determine the most appropriate fitting algorithm. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Mild to moderate bilateral hearing loss
- First time (new) hearing aid users or experienced hearing aid users
- Ability to use a smartphone
- Fluent in English; ability to read and write in English
- Willing and able to provide informed consent
Key exclusion criteria (3 listed)
- Self reported ear-related pathology including otorrhea within 90 days, dizziness, sudden onset or worsening of hearing loss within 90 days, visible deformity of the ear, otalgia
- Unilateral hearing loss
- Chronic, severe tinnitus
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 |
|---|---|---|
| Experimental hearing aidThis hearing aid is a receiver-in-canal style hearing aid which can be programmed and adjusted by proprietary software and by use with a mobile application. | Device | Fitting method A first, then fitting method B, Fitting method B first, then fitting method A |
Primary outcome
Abbreviated Profile of Hearing Aid Benefit (APHAB)
Time frame: Day 1 (unaided testing), Day 14(aided testing for first fitting method) and Day 28 (aided testing for second fitting method) of study
A validated questionnaire that assesses the subjective benefit of hearing aids in daily life. Participants rate their difficulty hearing in different situations, going from Always (99%), Almost Always (87%), Generally (75%), Half the time (50%), Occasionally (25%), Seldom (12%) or Never (1%). For example, the participant may choose "Always" to the statement "When I am having a quiet conversation with a friend, I have difficulty understanding". The questions are categorized into 4 different sub-scales: Ease of Communication (EC), Background Noise (BN), Reverberation (RV), and Aversiveness. The global score is calculated by taking the average of three of the subscales: EC, BN, and RV. The scores can range from 1% to 99%. Global Benefit is calculated by subtracting the aided global score from the unaided global score. The mean global benefit is calculated for each fitting method, and a higher benefit score is better. Result reported is the global benefit score for each fitting method.
1 secondary outcome
Speech Perception in Noise, Expressed in Decibel (dB) Signal to Noise Ratio (SNR) Loss
Time frame: Day 1 (unaided/baseline testing) of study, day 14 (aided testing with first fitting method) and day 28 (aided testing with second fitting method) of study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 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 Experimental 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 3 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 1 Sep 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 1 Sep 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?
Abbreviated Profile of Hearing Aid Benefit (APHAB) (time frame: Day 1 (unaided testing), Day 14(aided testing for first fitting method) and Day 28 (aided testing for second fitting method) of 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 1 Sep 2023; AzTrials last refreshed its copy on 29 Oct 2026.