An interventional study of Adhesive bone conduction hearing aid (ADHEAR - Med El) in Bone Conduction Deafness and Hearing Loss, Conductive, sponsored by Dominik Riss. Completed at 1 site in Austria. Open to participants aged 13 Years to 99 Years. Per ClinicalTrials.gov, last updated 2020-01-02.
Sponsored by Dominik Riss · Not applicable, Interventional, and Treatment
Patients implanted with a Bonebridge will be asked to be part of the study. The study subjects are enrolled into the study according to inclusion criteria.
Patients will be asked to wear an adhesive bone conduction device an adapt to it for 30-60 min. After this time period patients will be asked to use the adhesive device instead of the Bonebridge for 3 weeks. Audiologic Tests and quality of life questionnaires will be assessed at the beginning of the study and at the end of three weeks.
Phase 1 Patients will be fitted with an adhesive bone conduction device and asked to fill out two questionnaires. They will then wear the device for 30-60 minutes and decide if they want to wear the device for the remaining study time of three weeks. Patients who do not have sufficient benefit from the device or do not feel comfortable with it do not enter the second study period of wearing the device for three weeks. Patients will be asked to comment on their experiences after 30 to 60 minutes explaining why they do not want to enter the second part of the study if they feel comfortable sharing this information. Phase 2 Patients, in the second study period, will be asked to wear the hearing device as long as comfortable to them every day and mark time of device usage, battery life, changes of the adhesive adapter, sound quality and comfort related remarks in a diary. After three weeks patients will return to the outpatient ́s department for an audiological assessment and a second set of quality of hearing and quality of life questionnaire.
No patients will be implanted with a Bonebridge as part of the study.
Audiologic testing consists of sound field audiometry, Freiburg monosyllables test and Oldenburg sentence test.
Questionnaires consist of the AQol-8D and the SSQ-12
1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.
This study's enrollment of 19 is below the median of 40 across 764 interventional studies indexed under Hearing Loss.
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Exclusion Criteria:
Patients will be fitted with an adhesive bone conduction device for three weeks
Device: Adhesive bone conduction hearing aid (ADHEAR - Med El)
Patients are asked to wear an adhesive bone conduction hearing device which is attached to the mastoid with an adhesive adapter
Average functional hearing gain
The primary endpoint of the study is the average functional hearing gain evaluated by the free field audiometry (at 4 different frequencies) using the bone conduction device compared to the unaided situation. To compare the two hearing devices the following primary endpoint measure will be calculated: Δmean= {(Average functional hearing gain with Bonebridge - Average functional hearing gain with ADHEAR at timepoint T1 (=Δ1)) + (Average functional hearing gain with Bonebridge - Average functional hearing gain with ADHEAR at timepoint T2 (=Δ2))} divided by two. Measuring both hearing devices at both timepoints and using the mean difference (Δmean) enables adjustment for a possible underlying customization effect.
Time frame: 3 weeks
AQoL-8D (quality of life)
Will be measured by comparing Quality of Life as assessed with AQoL - 8D at the beginning of the study and the end of the study (The result of the AQoL-8D is a number)
Time frame: 3 weeks
Quality of hearing
Quality of hearing as assessed with the SSQ 12 questionnaire will be compared at the beginning of the study to the results after the three weeks with the adhesive device. The results of the SSQ-12 is a number
Time frame: 3 weeks
Word recognition score
Further secondary outcomes will be assessed by comparing the results of the word recognition test in the aided condition once with the implanted device (Bonebridge) in comparison to the adhesive device (ADHEAR). Word recognition is measured in percent at two different noise levels
Time frame: 3 weeks
Sentence test
Further secondary outcomes will be assessed by comparing the results of the sentence test in the aided condition once with the implanted device (Bonebridge) in comparison to the adhesive device (ADHEAR). Sentence test results are measured as percent at a certain volume level (dB).
Time frame: 3 weeks
Plan to share: No
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This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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