Health TrialsbyHealthPanel

Evaluation of Actual Maximum Gain in Bone Anchored Devices

ConditionMixed Hearing Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOticon Medical

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Sequential

Treatments tested in this trial

  • Bone Anchored Device A

    Device

    Fitting Device A

  • Bone Anchored Device B

    Device

    Fitting Device B

  • Bone Anchored Device C

    Device

    Fitting Device C

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: All study participantsExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oticon Medical

Lead sponsor

Göteborg University

Collaborator

Source ClinicalTrials.gov
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