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RECRUITING
NCT06039332
NA

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

Sponsor: Hospital Universitario La Paz

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1

Start Date

2023-06-27

Completion Date

2026-06-27

Last Updated

2023-09-15

Healthy Volunteers

Yes

Interventions

PROCEDURE

Fitting of the audioprocessor with the auditory implant BCI602

to compare the performance with BB system in two fitting-configurations (active comparator: DSL v5, experimental: DSL-BCD) using audiometric and subjective measures

Locations (1)

Hospital Universitario La Paz

Madrid, Spain