Comparative Study of Non-surgical Hearing Devices Based on Bone Conduction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-84
SponsorOticon Medical
About this trial
This study will investigate the performance of four non-surgical bone conduction devices.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Sequential
Treatments tested in this trial
Bone conduction devices
Other interventionBone Anchored device A Bone Anchored device B Bone Anchored device C Bone Anchored device D
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Arm 1Other 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, at fittingSecondary outcomes
1
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.
Time frame
Baseline, at fitting2
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.
Time frame
Baseline, at fittingSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: