An interventional study of Bone Anchored Device A and Bone Anchored Device B in Mixed Hearing Loss, sponsored by Oticon Medical. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-19.
Sponsored by Oticon Medical · Not applicable, Interventional, and Other
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.
44 studies on the registry are indexed under Hearing Loss, Mixed Conductive-Sensorineural; 9 are open to participants now.
This study's planned enrollment of 20 is below the median of 25 across 33 interventional studies indexed under Hearing Loss, Mixed Conductive-Sensorineural.
Browse Hearing Loss, Mixed Conductive-Sensorineural studies →Oticon Medical is the lead sponsor of 45 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All study patients will sequentially be measured with Device A, Device B and Device C
Device: Bone Anchored Device A · Device: Bone Anchored Device B · Device: Bone Anchored Device C
Fitting Device A
Fitting Device B
Fitting Device C
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
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
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2025 (actual). Primary completion is estimated for Jan 2026, 1 month after the start.
Of 24 industry-sponsored interventional studies with no phase under Hearing Loss, Mixed Conductive-Sensorineural, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 19. This study's planned 1 month is below that.
Counting every sponsor, half of 26 studies reached it within 12 months; a quarter within 5 and three quarters within 24.
How these figures are worked out, and which studies are left out of them.
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Hearing Loss, Mixed Conductive-Sensorineural →