Mixed Hearing LossNCT07580287
Comparative Study of Non-surgical Hearing Devices Based on Bone Conduction
A study testing Bone conduction devices in people with Mixed Hearing Loss and Conductive Hearing Loss, run by Oticon Medical at 1 site in Sweden.
Trial summary
This study will investigate the performance of four non-surgical bone conduction devices. Read more about this study
- Who is it for?
- Ages 18 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Mixed Hearing Loss, Conductive Hearing Loss
- What is being tested?
- Bone conduction devices
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jun 2026to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 84 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed Informed Consent Form
- Adults (from 18 to 84 years)
- Pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) less than 25 dB HL on both ears
- Fluent in Swedish to be able to read and understand patient information and informed consent process
Who cannot join
- Participation in another clinical investigation which might cause interference with study participation.
- Participants who do not have the ability or are unwilling to follow investigational procedures/requirements, e.g. to complete questionnaires, according to investigator's discretion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Chalmers
Gothenburg
Louise Waldenby, +46735165389, lowd@oticonmedical.com
About this study
This study will investigate the performance of four non-surgical bone conduction devices.
- Conditions
- Mixed Hearing Loss, Conductive Hearing Loss
- Being tested
- Bone conduction devices
- Keywords
- Bone conduction hearing devices, conductive hearing loss, mixed hearing loss, bone conduction
- Medical subject headings
- Hearing Loss, Mixed Conductive-Sensorineural, Hearing Loss, Conductive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone conduction devicesOther
Bone Anchored device A Bone Anchored device B Bone Anchored device C Bone Anchored device D
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Device:
Bone Anchored device A Bone Anchored device B Bone Anchored device C Bone Anchored device D Receives: Other: Bone conduction devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in aided thresholds between device A and device B for PTA4.
PTA4 is the calculated average hearing thresholds at frequencies 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz.
Measured: Baseline, at fitting
Secondary outcomes (2)
Difference in aided thresholds between device A and device C for PTA4.
PTA4 is the calculated average hearing thresholds at frequencies 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz.
Measured: Baseline, at fitting
Difference in aided thresholds between device A and device D for PTA4.
PTA4 is the calculated average hearing thresholds at frequencies 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz.
Measured: Baseline, at fitting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mixed 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oticon Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07580287
- Sponsor's protocol ID
- BC124
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 12 May 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 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Non-surgical Hearing Devices Based on Bone Conduction
- ClinicalTrials.gov ID
- NCT07580287
- Acronym / sponsor ID
- BC124
- Conditions
- Mixed Hearing Loss, Conductive Hearing Loss
- Keywords
- Bone conduction hearing devices, conductive hearing loss, mixed hearing loss, bone conduction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Oticon MedicalIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 12 May 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.
This study will investigate the performance of four non-surgical bone conduction devices.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Other: Bone conduction devicesDevice: Bone Anchored device A Bone Anchored device B Bone Anchored device C Bone Anchored device D |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed Informed Consent Form
- Adults (from 18 to 84 years)
- Pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) less than 25 dB HL on both ears
- Fluent in Swedish to be able to read and understand patient information and informed consent process
Key exclusion criteria (2 listed)
- Participation in another clinical investigation which might cause interference with study participation.
- Participants who do not have the ability or are unwilling to follow investigational procedures/requirements, e.g. to complete questionnaires, according to investigator's discretion.
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 |
|---|---|---|
| Bone conduction devicesBone Anchored device A Bone Anchored device B Bone Anchored device C Bone Anchored device D | Other | Arm 1 |
Primary outcome
Difference in aided thresholds between device A and device B for PTA4.
Time frame: Baseline, at fitting
PTA4 is the calculated average hearing thresholds at frequencies 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz.
2 secondary outcomes
Difference in aided thresholds between device A and device C for PTA4.
Time frame: Baseline, at fitting
Difference in aided thresholds between device A and device D for PTA4.
Time frame: Baseline, at fitting
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone conduction devices in people with Mixed Hearing Loss and Conductive Hearing Loss, run by Oticon Medical at 1 site in Sweden.
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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 12 May 2026. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Louise Waldenby (+46735165389, lowd@oticonmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in aided thresholds between device A and device B for PTA4. (time frame: Baseline, at fitting). 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 12 May 2026.