Audiological and Quality of Life Outcomes of Anatomy Based Fitting in Patients Implanted by Robot Assisted Cochlear Implant Surgery (RACIS) (RACIS ABF)

Universitair Ziekenhuis Brussel

Status

Enrolling

Conditions

Cochlear Implants

Sensorineural Hearing Loss, Bilateral

Treatments

Device: Fitting according to clinical standard followed by post-operative ABF

Device: Post-operative ABF followed by fitting according to clinical standard

Study type

Interventional

Funder types

Other

Identifiers

NCT05369598

EC-2022-022

Details and patient eligibility

About

Severe to profound hearing loss affects 0,8% of the global population. For these people, a conventional hearing aid often does not provide sufficient benefit. However, these people can benefit from a cochlear implant (CI). A CI needs to be individually programmed (fitted) for each recipient. A fitting "map" is defined as a set of electrical parameters that are individually adapted to a recipient's needs to achieve optimal sound perception. At present, most CI recipients are fitted with a default frequency allocation map that doesn't take individual variability in size and shape of the cochlea into account. In this study, a fitting strategy based on the post-operative CT scan, that will allow the audiologist to set a frequency-band distribution for CI fitting that may be more closely aligned to the natural tonotopic frequency distribution of a normal hearing cochlea, will be evaluated. This study will focus on patients that are already implanted with the HEARO robotic system.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age ≥ 18 years
Post-lingual onset of severe to profound sensory-neural hearing loss in the implanted ear(s)
Subject implanted by Robot Assisted Cochlear Implant Surgery (RACIS)
Subject implanted with MED-EL cochlear implant(s) with Flex28, Flex 26 or FlexSoft electrode to obtain maximum cochlear coverage
Subject planned to receive a MED-EL SONNET 2 or RONDO 3 audio processor on the newly implanted side
Subject is either a user with unilateral implantation, bilateral implantation or a bimodal CI user (unilateral CI user with contralateral ear adequately fitted with a hearing aid)
Pre- operative and post-operative CT scan of the temporal bone available
Pre-operative result of pure-tone audiometry, speech test in quiet and in noise available
Audio processor not yet activated on the newly implanted side
Minimum of 10 active channels can be activated
Fluent in the language of the test centre (Dutch or French)
Signed and dated ICF before the start of any study-specific procedure

Exclusion criteria

Subject is a Single-Sided Deafness (SSD) CI user
Subject is an Electric Acoustic Stimulation (EAS) user (with an EAS audio processor)
Lack of compliance with any inclusion criteria
Anything that, in the opinion of the Investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study