Mixed Hearing LossNCT07294976
Evaluation of Actual Maximum Gain in Bone Anchored Devices
A study testing Bone Anchored Device A, Bone Anchored Device B and Bone Anchored Device C in people with Mixed Hearing Loss, run by Oticon Medical at 1 site in Sweden.
Trial summary
This study will look at how much sound amplification (gain) different bone-anchored hearing devices can provide. The goal is to understand if there are differences between devices and whether these differences affect how well the devices meet the hearing needs of users. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mixed Hearing Loss
- What is being tested?
- Bone Anchored Device A, Bone Anchored Device B and Bone Anchored Device C
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 4 Dec 2025to 15 Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BAHS user with an Oticon Medical compatible abutment
- Signed Informed Consent Form
- Adult, 18 years or older
- MHL with pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of 25-65dB HL on the indicated ear
- MHL with an air-bone-gap (difference between BC and AC thresholds) of at least 15 dB measured at 0.5, 1, 2 and 3 kHz
- At least 3 months of experience using a bone conduction device.
- 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.
- Subjects 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, 1 recruiting
- Recruiting
Göteborgs Universitet
Gothenburg
Sadeghi, +46737531418, andre.sadeghi@neuro.gu.se
About this study
This study will look at how much sound amplification (gain) different bone-anchored hearing devices can provide. The goal is to understand if there are differences between devices and whether these differences affect how well the devices meet the hearing needs of users.
Bone-anchored hearing systems send sound vibrations directly to the inner ear through a small implant in the skull. The amount of amplification a device can provide is important for people with hearing loss. However, the actual maximum amplification available to a user depends on feedback control during fitting and can vary between devices and individuals.
In this study, the actual maximum amplification of Device A and Device B will be compared. In addition the actual maximum amplification of Device A will be compared to Device C as well as the Device B compared to Device C. It will also be investigated whether the amplification limits the prescribed settings for the users.
- Conditions
- Mixed Hearing Loss
- Being tested
- Bone Anchored Device A, Bone Anchored Device B, Bone Anchored Device C
- Medical subject headings
- Hearing Loss, Mixed Conductive-Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Anchored Device ADevice
Fitting Device A
Bone Anchored Device BDevice
Fitting Device B
Bone Anchored Device CDevice
Fitting Device C
| Study group | Role | What they receive |
|---|---|---|
| All study participants | Experimental | All study patients will sequentially be measured with Device A, Device B and Device C Receives: Device: Bone Anchored Device A; Device: Bone Anchored Device B; Device: Bone Anchored Device C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in actual maximum gain in dB, between Device A compared to Device B for the mean average of the frequencies 500, 1000, 2000, 3000 and 4000
Measured: Baseline, at fitting
Secondary outcomes (6)
Difference in actual maximum gain in dB, between Device A compared to Device B for the for the mean average of the frequencies 500, 1000, 2000 and 4000
Measured: Baseline, at fitting
Difference in actual maximum gain in dB, between Device A compared to Device B across frequencies 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 kHz
Measured: Baseline, at fitting
Difference in actual maximum gain in dB, between Device C compared to Device B for the mean average of the frequencies 500, 1000, 2000, 3000 and 4000
Measured: Baseline, at fitting
Difference in actual maximum gain in dB, between Device C compared to Device B for the mean average of the frequencies 500, 1000, 2000 and 4000
Measured: Baseline, at fitting
Difference in actual maximum gain in dB, between Device C compared to Device B across frequencies 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 kHz
Measured: Baseline, at fitting
Number of subjects with a limitation of the prescribed gain in any frequency band with Device A, Device B and Device C
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 posted19 Dec 2025
- Study start4 Dec 2025
- Primary completion15 Jan 2026 (estimated)
- Study completion15 Jan 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)
- Collaborators
- Göteborg University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07294976
- Sponsor's protocol ID
- BC126
- Status last verified
- Dec 2025
- First submitted
- 27 Nov 2025
- Last updated
- 19 Dec 2025
- 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 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Actual Maximum Gain in Bone Anchored Devices
- ClinicalTrials.gov ID
- NCT07294976
- Acronym / sponsor ID
- BC126
- Conditions
- Mixed Hearing Loss
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Oticon MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Göteborg University
- Study start
- 4 Dec 2025 (actual)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 15 Jan 2026 (estimated)
- First posted
- 19 Dec 2025 (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 look at how much sound amplification (gain) different bone-anchored hearing devices can provide. The goal is to understand if there are differences between devices and whether these differences affect how well the devices meet the hearing needs of users.
Bone-anchored hearing systems send sound vibrations directly to the inner ear through a small implant in the skull. The amount of amplification a device can provide is important for people with hearing loss. However, the actual maximum amplification available to a user depends on feedback control during fitting and can vary between devices and individuals.
In this study, the actual maximum amplification of Device A and Device B will be compared. In addition the actual maximum amplification of Device A will be compared to Device C as well as the Device B compared to Device C. It will also be investigated whether the amplification limits the prescribed settings for the users.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All study participants | Experimental | Device: Bone Anchored Device A, Device: Bone Anchored Device B, Device: Bone Anchored Device CAll study patients will sequentially be measured with Device A, Device B and Device C |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- BAHS user with an Oticon Medical compatible abutment
- Signed Informed Consent Form
- Adult, 18 years or older
- MHL with pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of 25-65dB HL on the indicated ear
- MHL with an air-bone-gap (difference between BC and AC thresholds) of at least 15 dB measured at 0.5, 1, 2 and 3 kHz
Key exclusion criteria (2 listed)
- Participation in another clinical investigation which might cause interference with study participation.
- Subjects 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 Anchored Device AFitting Device A | Device | All study participants |
| Bone Anchored Device BFitting Device B | Device | All study participants |
| Bone Anchored Device CFitting Device C | Device | All study participants |
Primary outcome
Difference in actual maximum gain in dB, between Device A compared to Device B for the mean average of the frequencies 500, 1000, 2000, 3000 and 4000
Time frame: Baseline, at fitting
6 secondary outcomes
Difference in actual maximum gain in dB, between Device A compared to Device B for the for the mean average of the frequencies 500, 1000, 2000 and 4000
Time frame: Baseline, at fitting
Difference in actual maximum gain in dB, between Device A compared to Device B across frequencies 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 kHz
Time frame: Baseline, at fitting
Difference in actual maximum gain in dB, between Device C compared to Device B for the mean average of the frequencies 500, 1000, 2000, 3000 and 4000
Time frame: Baseline, at fitting
Difference in actual maximum gain in dB, between Device C compared to Device B for the mean average of the frequencies 500, 1000, 2000 and 4000
Time frame: Baseline, at fitting
Difference in actual maximum gain in dB, between Device C compared to Device B across frequencies 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 kHz
Time frame: Baseline, at fitting
Number of subjects with a limitation of the prescribed gain in any frequency band with Device A, Device B and Device C
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 19 Dec 2025.
- 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 Anchored Device A, Bone Anchored Device B and Bone Anchored Device C in people with Mixed 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 7 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: looking for participants now, as of the sponsor's last update on 19 Dec 2025. 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 Marianne Philipsson Senior Clinical Trial Manager (+46 (0)70 098 17 15, maph@oticonmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in actual maximum gain in dB, between Device A compared to Device B for the mean average of the frequencies 500, 1000, 2000, 3000 and 4000 (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 19 Dec 2025.