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

Launched by HOSPITAL UNIVERSITARIO LA PAZ · Sep 9, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the Bonebridge (BCI602), a special hearing device designed to help people with certain types of hearing loss, specifically conductive and mixed hearing loss. The trial aims to find out if patients experience better hearing and satisfaction with the Bonebridge when using two different fitting strategies: one standard method (DSL v5) and a newer method developed specifically for bone conduction devices (DSL-BCD). Participants will be evaluated on how well they hear and how they feel about the device compared to not using it at all.

To be eligible for this study, you must be at least 18 years old and have been implanted with the Bonebridge device. You should have either unilateral (one ear) or bilateral (both ears) conductive or mixed hearing loss. It’s important that you are able to use the hearing system and participate in all required tests. If you have certain severe types of hearing loss or other medical conditions that could affect your ability to participate, you may not be eligible. Participants can expect to undergo various tests and comparisons to assess the effectiveness of the different fitting strategies. This study is currently recruiting participants of all genders, and your involvement could help advance understanding of how to improve hearing for others in similar situations.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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.
• • Fluctuating hearing loss.