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OpenTrials
Completed

NCT Number: NCT03766152

Audiological Benefit and Improved Quality of Life With Two Bone Conduction Systems: ADHEAR vs. Bonebridge in Experienced Users

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.

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Key information

Conditions

Bone Conduction Deafness Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Conductive Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

13 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MUW, AKH

Vienna, 1090, Austria

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients implanted with a Bonebridge device and are active users
  • Unilateral and/or bilateral conductive hearing loss (CHL)
  • Subjects aged 13 years or older
  • Capable of the German language
  • Willingness and ability to perform all tests required for the study
  • Signed, and dated informed consent before the start of any study specific procedure

Exclusion criteria

  • Pregnancy or breastfeeding
  • Patient is intolerant of the materials as described by Manufacturer's IFU
  • Patient presents with a skin or scalp condition that may preclude the attachment of the adhesive adapter.
  • Patient cannot perform the audiological tests or is unable to fill out the questionnaires.
  • Patient presents with retrocochlear, or central auditory disorder.
  • any physical, psychological, or emotional disorder that would interfere with the ability to perform on test and rehabilitation procedures

Treatment and study plan

Adhesive bone conduction hearing aid (ADHEAR - Med El)

Device

Patients are asked to wear an adhesive bone conduction hearing device which is attached to the mastoid with an adhesive adapter

Primary outcomes

  1. Average functional hearing gain

    Time frame: 3 weeks

    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.

Secondary outcomes

  1. AQoL-8D (quality of life)

    Time frame: 3 weeks

    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)

  2. Quality of hearing

    Time frame: 3 weeks

    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

  3. Word recognition score

    Time frame: 3 weeks

    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

  4. Sentence test

    Time frame: 3 weeks

    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).

Sponsors and collaborators

Lead sponsor

Dominik Riss

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 6, 2018
Registry last updated
Jan 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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