Hearing LossNCT04882787
Validation of Novel BTE and SP Hearing Aid Models
A study testing BTE hearing aid in people with Hearing Loss, run by Sonova AG at 1 site in Canada.
Trial summary
Participants will wear one set of 2 different BTE hearing aid models based on the gain required by their hearing loss. The hearing aids will be programmed based on a prescriptive approach and participants will be sent out for either one home trial with the less powerful BTEs or for two home trials with the SP (super… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hearing Loss
- What is being tested?
- BTE hearing aid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- 14 May 2021to 13 Jul 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hearing aid candidacy (N2-N7 hearing loss)
- healthy outer and middle ears
- ability to complete questionnaires
- willingness to use smartphone
- informed consent documented by a signature
- willingness to wear a binaural BTE fitting
- willingness to use app and accessories
- willingness to adhere to COVID protocols
Who cannot join
- contraindications to the MD in this study: known hypersensitivity or allergy to investigational product/earmold
- limited mobility/not able to attend appointments
- limited ability to describe listening impressions/experiences
- inability to produce a reliable hearing test result
- limited dexterity - to point that participant cannot manage hearing aid insertion/removal
- known psychological disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of 2 Novel BTE Hearing Aid Models Varying With Respect to Regular-power or Super-power Gain Specifications
Participants will wear one set of 2 different BTE hearing aid models based on the gain required by their hearing loss. The hearing aids will be programmed based on a prescriptive approach and participants will be sent out for either one home trial with the less powerful BTEs or for two home trials with the SP (super power) BTEs.
Read the detailed description
During this study each participant will be asked to wear a set of BTE hearing aids home and wear them daily. We will be assessing their evaluation of the BTEs during and after their home field trial. They will be asked to report on their use with different apps/accessories. Subjective performance ratings will be collected.
- Conditions
- Hearing Loss
- Being tested
- BTE 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.
BTE hearing aidDevice
Amplification
| Study group | Role | What they receive |
|---|---|---|
| BTE hearing aid model | Experimental | BTE or SP-BTE (super power) hearing aid fitting Receives: Device: BTE hearing aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With 'Total Impression' Sound Quality as 'Good'
Participants with 'good' response of 7 or higher on 'Total Impression' scale; Gabrielsson citation/article includes seven perceptual scales and a scale for 'Total Impression' which is described as 'an overall judgment of how good you think the reproduction is'.
Possible scores from 0 to 10 with descriptors provided: 0 (min), 1 (very bad), 3 (rather bad), 5 (midway), 7 (rather good), 9 (very good), 10 (max) A higher score reflects a better outcome.
Measured: final appointment (end of 3 weeks home trial for BTE model, end of 7 weeks home trial for SP-BTE model)
Secondary outcomes (3)
Number and Percentage of Participants Reporting No Reboots
Participants to report perceived unwanted reboots of the hearing aids as an indicator of system stability (with use of 2.4 GHz connectivity including accessories and smartphones). Possible responses for perceived reboots (i.e., instances when the amplified sound dropped out and then returned) are: 'No (0) reboots perceived' or 'Reboots perceived (1 or more)'.
Measured: at any time during home trial, reported at or by final appointment(end of 3 weeks home trial for BTE model, end of 7 weeks home trial for SP-BTE model)
Number of Participants Reporting Perceived Differences With Both of the App Boost Controls
Number of SP-BTE participants reporting perceived differences from adjustment of the app's Boost controls.
Stimuli were presented in a sound room to check the Clarity \& Comfort Boosts in the app (available in Automatic Program). To comment on the effect of the Boosts, participants listened to simulated acoustic scenarios, initially under default settings (i.e., with no Boost), then with each Boost (Comfort then Clarity) activated separately (by pressing a button on a screen in the app).
Yes/No answer to confirm a perceived difference -- 'Did you notice a difference?'
Measured: initial appointment (day of fitting of hearing aids)
Number of Participants Reporting Perceived Differences With Both of the App Slider Controls
Number of SP-BTE participants reporting perceived differences from adjustment of two of the app's Slider controls.
Stimuli were presented in a sound room to check the Enhance Speech and Reduce Noise sliders in the app (available in Manual Program). To comment on the effect of the Sliders, participants were asked to adjust the Enhance Speech and Reduce Noise Sliders (separately) to the Maximum and Minimum settings (by sliding the setting indicator across the available range).
Yes/No answer to confirm a perceived difference -- 'Did you notice a difference?'
Measured: initial appointment (day of fitting of hearing aids)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start14 May 2021
- Primary completion13 Jul 2021
- Study completion13 Jul 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.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Model description
- 2 groups based on hearing aid gain needs; one similar intervention
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonova AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sonova Canada Inc.
- Responsible party
- Sponsor
- Investigators
- Jinyu Qian, PhD, Principal investigator, Sonova AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04882787
- Sponsor's protocol ID
- 378
- Status last verified
- Jun 2023
- First submitted
- 4 May 2021
- Last updated
- 12 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gabrielsson A, Schenkman BN, Hagerman B. The effects of different frequency responses on sound quality judgments and speech intelligibility. J Speech Hear Res. 1988 Jun;31(2):166-77. doi: 10.1044/jshr.3102.166.
PubMed 3398490Valente M, Van Vliet D. The Independent Hearing Aid Fitting Forum (IHAFF) Protocol. Trends Amplif. 1997 Mar;2(1):6-35. doi: 10.1177/108471389700200102. No abstract available.
PubMed 25425874Likert, Rensis. A technique for the measurement of attitudes. Archives of Psychology. 1932; 140: 1-55.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of 2 Novel BTE Hearing Aid Models Varying With Respect to Regular-power or Super-power Gain Specifications
- ClinicalTrials.gov ID
- NCT04882787
- Acronym / sponsor ID
- 378
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Collaborators
- Sonova Canada Inc.
- Study start
- 14 May 2021 (actual)
- Primary completion
- 13 Jul 2021 (actual)
- Study completion
- 13 Jul 2021 (actual)
- First posted
- 12 May 2021 (actual)
- Results
- Posted 12 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participants will wear one set of 2 different BTE hearing aid models based on the gain required by their hearing loss. The hearing aids will be programmed based on a prescriptive approach and participants will be sent out for either one home trial with the less powerful BTEs or for two home trials with the SP (super power) BTEs.
Detailed description
During this study each participant will be asked to wear a set of BTE hearing aids home and wear them daily. We will be assessing their evaluation of the BTEs during and after their home field trial. They will be asked to report on their use with different apps/accessories. Subjective performance ratings will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 2 groups based on hearing aid gain needs; one similar intervention
| Arm | Type | Receives |
|---|---|---|
| BTE hearing aid model | Experimental | Device: BTE hearing aidBTE or SP-BTE (super power) hearing aid fitting |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- hearing aid candidacy (N2-N7 hearing loss)
- healthy outer and middle ears
- ability to complete questionnaires
- willingness to use smartphone
- informed consent documented by a signature
Key exclusion criteria (6 listed)
- contraindications to the MD in this study: known hypersensitivity or allergy to investigational product/earmold
- limited mobility/not able to attend appointments
- limited ability to describe listening impressions/experiences
- inability to produce a reliable hearing test result
- limited dexterity - to point that participant cannot manage hearing aid insertion/removal
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 |
|---|---|---|
| BTE hearing aidAmplification | Device | BTE hearing aid model |
Primary outcome
Number of Participants With 'Total Impression' Sound Quality as 'Good'
Time frame: final appointment (end of 3 weeks home trial for BTE model, end of 7 weeks home trial for SP-BTE model)
Participants with 'good' response of 7 or higher on 'Total Impression' scale; Gabrielsson citation/article includes seven perceptual scales and a scale for 'Total Impression' which is described as 'an overall judgment of how good you think the reproduction is'. Possible scores from 0 to 10 with descriptors provided: 0 (min), 1 (very bad), 3 (rather bad), 5 (midway), 7 (rather good), 9 (very good), 10 (max) A higher score reflects a better outcome.
3 secondary outcomes
Number and Percentage of Participants Reporting No Reboots
Time frame: at any time during home trial, reported at or by final appointment(end of 3 weeks home trial for BTE model, end of 7 weeks home trial for SP-BTE model)
Number of Participants Reporting Perceived Differences With Both of the App Boost Controls
Time frame: initial appointment (day of fitting of hearing aids)
Number of Participants Reporting Perceived Differences With Both of the App Slider Controls
Time frame: initial appointment (day of fitting of hearing aids)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 3398490Gabrielsson A, Schenkman BN, Hagerman B. The effects of different frequency responses on sound quality judgments and speech intelligibility. J Speech Hear Res. 1988 Jun;31(2):166-77. doi: 10.1044/jshr.3102.166.
- Background: PubMed 25425874Valente M, Van Vliet D. The Independent Hearing Aid Fitting Forum (IHAFF) Protocol. Trends Amplif. 1997 Mar;2(1):6-35. doi: 10.1177/108471389700200102. No abstract available.
- BackgroundLikert, Rensis. A technique for the measurement of attitudes. Archives of Psychology. 1932; 140: 1-55.
- 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. This study is not recruiting at the moment.
Jinyu Qian, PhD principal investigator
Sonova AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BTE hearing aid in people with Hearing Loss, run by Sonova AG at 1 site in Canada.
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 8 inclusion and 6 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 12 Aug 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 Canada. 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 12 Aug 2024). 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?
Number of Participants With 'Total Impression' Sound Quality as 'Good' (time frame: final appointment (end of 3 weeks home trial for BTE model, end of 7 weeks home trial for SP-BTE model)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04882787, which also lists 3 linked publications.
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 12 Aug 2024.