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Subjective and Audiological Benefit of BONEBRIDGE (BCI602) With Two Different Fitting Strategies

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The Bonebridge (BB) is a partially implantable active transcutaneous bone conduction hearing system manufactured by MED-EL Elektromedizinische Geräte Gesellschaft m.b.H. (MED-EL, Innsbruck, Austria). The BB augments hearing by providing acoustic input to the inner ear via bone conduction. In 2017 Hodgetts \& Scollie introduced a new fitting algorithm called DSL-BCD. The DSL-BCD algorithm was developed especially for the characteristics of bone conduction devices (BCD). If there is a benefit on the patient level in hearing outcomes when comparing the application of DSL-BCD in comparison to DSL v5 when using the BB, was not yet investigated. The aim of this clinical study is to show the improvement in audiological performance and subjective satisfaction with the BCI602 and SAMBA 2 audio processor in patients with conductive hearing loss compared to the unaided condition and to evaluate performance differences through application of 2 different fitting algorithms, namely DSL v5 and DSL-BCD.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 18 years of age or older

• Unilateral and/or bilateral conductive or mixed hearing loss (CHL/MHL) in indication range.

• Implanted with a BCI602 device.

• Willingness and ability to use the hearing system and to perform all tests required for the study

• Signed, and dated informed consent before the start of any study specific procedure

• Native speaker

Locations
Other Locations
Spain
Hospital Universitario La Paz
RECRUITING
Madrid
Contact Information
Primary
Javier Gavilan
javier.gavilan@salud.madrid.org
+34917270000
Backup
Miryam Calvino
miryamcf@yahoo.com
+34917270000
Time Frame
Start Date: 2023-06-27
Estimated Completion Date: 2026-06-27
Participants
Target number of participants: 1
Treatments
Experimental: Fittig with DSL-BCD
The new way of fitting the audioprocessor
Active_comparator: Fitting with DSL v5
The way of fitting the audioprocessor until now
Related Therapeutic Areas
Sponsors
Collaborators: MED-EL Elektromedizinische Geräte GesmbH
Leads: Hospital Universitario La Paz

This content was sourced from clinicaltrials.gov