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

NCT06039332 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2023-09-15

No results posted yet for this study

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.

Conditions

  • Bone Conduction Deafness
  • Quality of Life
  • Hearing Loss, Mixed

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

Sponsors & Collaborators

  • MED-EL Elektromedizinische Geräte GesmbH

    collaborator INDUSTRY

  • Hospital Universitario La Paz

    lead OTHER

Principal Investigators

  • Javier Gavilan · Hospital La Paz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-27
Primary Completion
2026-03-31
Completion
2026-06-27

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06039332 on ClinicalTrials.gov