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

NCT06039332 | Recruiting

• 1 other identifier: PI-6471
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (6)

• 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.

  12 weeks

• 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

  12 weeks

• 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

  12 weeks

• 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.

  12 weeks

• Subjective satisfaction evaluated by means of APHAB

  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 the Abbreviated Profile of Hearing Aid Benefit (APHAB) will be used. It is a 24-item questionnaire derived from the original 66-item Profile of Hearing Aid Benefit. The self-assessment instrument evaluates hearing impairment in real-life situations with and without hearing aids. Participants have to rate how often a given statement is true in their daily life, based on the following seven response alternatives: always (99%), almost always (87%), generally (75%), half-the-time (50%), occasionally (25%), seldom (12%) and never (1%). In the first three subscales, higher scores suggest less hearing disability, while lower scores indicate less hearing disability in the aversiveness subscale. The APHAB typically requires 10 minutes or less to complete.

  12 weeks

• Subjective satisfaction assessed by a custom made questionnaire

  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. A third, custom made questionnaire, will be filled out at two timepoints, after the acute test of condition A \& B in visit 2 and at the last visit. The questionnaire will ask the patient what condition A or B was preferred in visit 2. At the last visit (for the unexperienced users, and in the only visit for the experienced users) the patient will be asked what condition was preferred in several listening scenarios during the trial time.

  12 weeks

Study Arms (2)

Fittig with DSL-BCD

EXPERIMENTAL

The new way of fitting the audioprocessor

Procedure: Fitting of the audioprocessor with the auditory implant BCI602

Fitting with DSL v5

ACTIVE COMPARATOR

The way of fitting the audioprocessor until now

Procedure: Fitting of the audioprocessor with the auditory implant BCI602

Interventions

Fitting of the audioprocessor with the auditory implant BCI602 PROCEDURE

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

Fittig with DSL-BCD; Fitting with DSL v5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Fluctuating hearing loss.

Sponsors & Collaborators

• Hospital Universitario La Paz: lead
• MED-EL Elektromedizinische Geräte GesmbH: collaborator

Study Sites (1)

Hospital Universitario La Paz

Madrid, 28046, Spain

RECRUITING

MeSH Terms

Conditions

Hearing Loss, Mixed Conductive-Sensorineural

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 Officials

• Javier Gavilan

  Hospital La Paz

  STUDY CHAIR

Central Study Contacts

Javier Gavilan

CONTACT

+34917270000; javier.gavilan@salud.madrid.org

Miryam Calvino

CONTACT

+34917270000; miryamcf@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator, Member of the Research Department

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: September 15, 2023
• Study Start: June 27, 2023
• Primary Completion: March 31, 2026
• Study Completion (Estimated): June 27, 2026
• Last Updated: September 15, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)