Hearing LossNCT07414329
Efficacy and Effectiveness of an Investigational Behind-the-Ear Hearing Device Kit
A study testing Rechargeable behind-the-ear hearing device kit in people with Hearing Loss, run by Sonova AG at 2 sites in Canada.
Trial summary
The goal of this clinical trial is to learn if Sonova's rechargeable behind-the-ear hearing device kit works to treat hearing loss in adults. The main questions it aims to answer are: Does the rechargeable behind-the-ear hearing device kit address challenging listening situations identified by participants while… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Rechargeable behind-the-ear hearing device kit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesCanada
- Study dates
- 30 Jan 2026to 18 Mar 2026
- 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
- Adults (aged 18 years or older)
- Current and experienced hearing aid users (actively using hearing aids for at least 3 months)
- Audiograms that fit within the fitting range of the devices (mild to profound bilateral hearing loss)
- Cognitive and functional capability to consent to study procedures, operate the controls for the devices and comply with all directions during the study.
- Good understanding (read/write/speak) of the English language.
- Willingness to comply with all study requirements including minimum wear-time (6-8 hrs/day) of binaural BTE(RIC) investigational devices.
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- Good overall health including healthy outer ear with no excessive wax/debris.
- Ear canal size/shape must accommodate appropriate fitting of the hearing device.
- Socially engaged participants are a top priority (out \& active socially) who frequently encounter the noisy situations in which the devices are meant to be used.
- Use/ownership of a smartphone to pair hearing aids with for use with phone calls and streaming.
- Otherwise, the study population is representative of typical hearing instrument users in age and presence of hearing loss
Who cannot join
- Significant medical conditions that, in the opinion of the investigators, are likely to interfere with study procedures or likely to confound study endpoint.
- Contraindications to medical device (MD) in this study: known hypersensitivity or allergy to investigational product/domes.
- Limited ability to describe listening impressions/experiences and the use of the hearing aid.
- Acute tinnitus (<three months after onset).
- Inability to attend scheduled visits (mobility and/or scheduling).
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
National Hearing Services Inc
Kitchener, Ontario, N2E 1Y6
National Hearing Services Inc
Mississauga, Ontario, L5L1J3
About this study
Official title: Evaluation of Efficacy and Effectiveness of the Investigational Sonova Behind-the-Ear Rechargeable Hearing Device Kit 2 - 2025
The goal of this clinical trial is to learn if Sonova's rechargeable behind-the-ear hearing device kit works to treat hearing loss in adults. The main questions it aims to answer are:
- Does the rechargeable behind-the-ear hearing device kit address challenging listening situations identified by participants while providing a satisfactory user experience?
- Does the rechargeable behind-the-ear hearing device kit improve speech understanding in noise in a lab setting?
Read more
Researchers will compare participants' performance with the rechargeable behind-the-ear hearing device kit to the unaided condition to see if it works to treat hearing loss. The rechargeable behind-the-ear hearing device kit will be subjectively compared to their personal hearing device experience.
Participants will:
- Use the rechargeable behind-the-ear hearing device kit for approximately 2 weeks.
- Visit the clinic for the initial fitting and follow-up testing at the end of the study. Additional study visits may take place, as needed.
- Complete questionnaires to identify challenging listening situations and provide feedback on their experience with the devices.
- Complete lab testing to assess speech intelligibility in the presence of background noise and provide subjective feedback on features in the Mobile application.
- Conditions
- Hearing Loss
- Being tested
- Rechargeable behind-the-ear hearing device kit
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rechargeable behind-the-ear hearing device kitDevice
This intervention includes the following components: hearing aid, charger, applicable accessories
| Study group | Role | What they receive |
|---|---|---|
| Hearing device kit users | Experimental | Participants will use the rechargeable behind-the-ear hearing device kit for the duration of their study participation in the lab and during their take home trial. Receives: Device: Rechargeable behind-the-ear hearing device kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective questionnaire feedback
Participants will complete subjective feedback questionnaires: Client Oriented Scale of Improvement (COSI), Online questionnaire, Mobile Application questionnaire. Results will be analyzed descriptively to assess the user experience with the hearing device kit.
Measured: From enrollment to the end of treatment at 2 weeks
Secondary outcomes (1)
Hearing in Noise Test (HINT)
An assessment of speech understanding in the presence of background noise in the lab setting.
Measured: At the end of treatment, after two weeks of device use.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start30 Jan 2026
- Primary completion18 Mar 2026
- Study completion18 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonova AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Hearing Services Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07414329
- Sponsor's protocol ID
- SRF-33501
- Other IDs
- 401131
- Status last verified
- Aug 2026
- First submitted
- 9 Feb 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Effectiveness of the Investigational Sonova Behind-the-Ear Rechargeable Hearing Device Kit 2 - 2025
- ClinicalTrials.gov ID
- NCT07414329
- Acronym / sponsor ID
- SRF-33501
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Collaborators
- National Hearing Services Inc
- Study start
- 30 Jan 2026 (actual)
- Primary completion
- 18 Mar 2026 (actual)
- Study completion
- 18 Mar 2026 (actual)
- First posted
- 17 Feb 2026 (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.
The goal of this clinical trial is to learn if Sonova's rechargeable behind-the-ear hearing device kit works to treat hearing loss in adults. The main questions it aims to answer are:
- Does the rechargeable behind-the-ear hearing device kit address challenging listening situations identified by participants while providing a satisfactory user experience?
- Does the rechargeable behind-the-ear hearing device kit improve speech understanding in noise in a lab setting?
Researchers will compare participants' performance with the rechargeable behind-the-ear hearing device kit to the unaided condition to see if it works to treat hearing loss. The rechargeable behind-the-ear hearing device kit will be subjectively compared to their personal hearing device experience.
Participants will:
- Use the rechargeable behind-the-ear hearing device kit for approximately 2 weeks.
- Visit the clinic for the initial fitting and follow-up testing at the end of the study. Additional study visits may take place, as needed.
- Complete questionnaires to identify challenging listening situations and provide feedback on their experience with the devices.
- Complete lab testing to assess speech intelligibility in the presence of background noise and provide subjective feedback on features in the Mobile application.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hearing device kit users | Experimental | Device: Rechargeable behind-the-ear hearing device kitParticipants will use the rechargeable behind-the-ear hearing device kit for the duration of their study participation in the lab and during their take home trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adults (aged 18 years or older)
- Current and experienced hearing aid users (actively using hearing aids for at least 3 months)
- Audiograms that fit within the fitting range of the devices (mild to profound bilateral hearing loss)
- Cognitive and functional capability to consent to study procedures, operate the controls for the devices and comply with all directions during the study.
- Good understanding (read/write/speak) of the English language.
Key exclusion criteria (5 listed)
- Significant medical conditions that, in the opinion of the investigators, are likely to interfere with study procedures or likely to confound study endpoint.
- Contraindications to medical device (MD) in this study: known hypersensitivity or allergy to investigational product/domes.
- Limited ability to describe listening impressions/experiences and the use of the hearing aid.
- Acute tinnitus (<three months after onset).
- Inability to attend scheduled visits (mobility and/or scheduling).
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 |
|---|---|---|
| Rechargeable behind-the-ear hearing device kitThis intervention includes the following components: hearing aid, charger, applicable accessories | Device | Hearing device kit users |
Primary outcome
Subjective questionnaire feedback
Time frame: From enrollment to the end of treatment at 2 weeks
Participants will complete subjective feedback questionnaires: Client Oriented Scale of Improvement (COSI), Online questionnaire, Mobile Application questionnaire. Results will be analyzed descriptively to assess the user experience with the hearing device kit.
1 secondary outcome
Hearing in Noise Test (HINT)
Time frame: At the end of treatment, after two weeks of device use.
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 11 Aug 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rechargeable behind-the-ear hearing device kit in people with Hearing Loss, run by Sonova AG at 2 sites 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 11 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 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Subjective questionnaire feedback (time frame: From enrollment to the end of treatment at 2 weeks). 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 11 Aug 2026.