Subjective and Audiological Benefit of BONEBRIDGE (BCI602) With Two Different Fitting Strategies
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Universitario La Paz
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Profound unilateral sensorineural hearing loss, often termed Single sided deafness (SSD)
Retrocochlear, or central auditory disorders
Any physical, psychological, or emotional disorder that would interfere with the ability to perform on test and rehabilitation procedures
Subjects who do not meet one or more of the above mentioned inclusion criteria are excluded from the study.
Trial design
Design model
Parallel
Treatments tested in this trial
Fitting of the audioprocessor with the auditory implant BCI602
Procedure/Surgeryto compare the performance with BB system in two fitting-configurations (active comparator: DSL v5, experimental: DSL-BCD) using audiometric and subjective measures
Treatment groups
1 Participants
are divided into 2 treatment groupsGroup A: Fittig with DSL-BCDExperimental treatment 1 intervention
Group B: Fitting with DSL v5Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Audiological performance with both ways of fitting
Standard audiometry Sound field testing will be conducted in quiet with the subject sitting one meter from the loudspeakers. The volume control of the device shall be set at the most comfortable level for the sound field tests.
Time frame
12 weeks2
Speech performance in quiet with both ways of fitting
Speech audiometry in quiet The word recognition score will be measured in quiet. The test in quiet shall be conducted with the speaker at 0° azimuth (S0) with 1 meter distance from the center of the subject's head and at ear level. Spanish speech material (recorded): Cardenas and Marrero balanced word list. 100% will be considered as the maximum outcome
Time frame
12 weeks3
Speech performance in noise with both ways of fitting
Speech audiometry in noise For measuring speech intelligibility in noise the International Matrix Test is used with fixed noise level at 65 dB SPL and speech level at 65 dB SPL from S0N0 (speech and noise coming from the front). One list comprises 20 sentences with 5 words in each sentence. A negative value means, better performance
Time frame
12 weeks4
Subjective satisfaction measured with SSQ12
Questionnaires A hearing specific questionnaire will be filled out per participant, in 3 conditions, unaided (preoperatively), aided with BB in fitting condition A and aided with Bonebridge in fitting condition B. The Spanish version of Speech, Spatial, and Qualities of Hearing Questionnaire with 12 items (SSQ12) will be used. It is designed to measure self-reported auditory disability across a wide variety of domains, reflecting the reality of hearing in the everyday world. It takes approximately 5 minutes to complete. It consists of 12 questions that the subjects score on a scale from 0 (not at all) to 10 (perfectly). The total score is the sum of all items and can range between 0 and 120. The higher score, the better outcomes.
Time frame
12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hospital Universitario La Paz
Lead sponsor
MED-EL Elektromedizinische Geräte GesmbH
Collaborator
Source ClinicalTrials.gov