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

NCT03766152 | Completed

• 1 other identifier: 1757/2018
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bone Conduction Deafness; Hearing Loss, Conductive

Keywords

Hearing aid

Outcome Measures

Primary Outcomes (1)

• 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.

  3 weeks

Secondary Outcomes (4)

• AQoL-8D (quality of life)

  3 weeks

• Quality of hearing

  3 weeks

• Word recognition score

  3 weeks

• Sentence test

  3 weeks

Study Arms (1)

Adhear

OTHER

Patients will be fitted with an adhesive bone conduction device for three weeks

Device: Adhesive bone conduction hearing aid (ADHEAR - Med El)

Interventions

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

Adhear

Eligibility Criteria

• Age: 13 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dominik Riss: lead

Study Sites (1)

MUW, AKH

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Hearing Loss, Conductive

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc. Prof PD Dr.

Study Record Dates

• First Submitted: November 16, 2018
• First Posted: December 6, 2018
• Study Start: November 1, 2018
• Primary Completion: October 31, 2019
• Study Completion: December 13, 2019
• Last Updated: January 2, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)