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

NCT05369598 | Unknown

• 1 other identifier: EC-2022-022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cochlear Implants; Sensorineural Hearing Loss, Bilateral

Outcome Measures

Primary Outcomes (3)

• Speech recognition in noise: Speech Reception Threshold (SRT) in dB SNR

  3 months post- activation

• Speech recognition in noise: Speech Reception Threshold (SRT) in dB SNR

  6 months post- activation

• Speech recognition in noise: Speech Reception Threshold (SRT) in dB SNR

  8 months post-activation

Secondary Outcomes (22)

• Speech recognition in quiet: Percentage correctly identified phonemes

  3 months post-activation

• Speech recognition in quiet: Percentage correctly identified phonemes

  6 months post-activation

• Speech recognition in quiet: Percentage correctly identified phonemes

  8 months post-activation

• Speech discrimination: Number of correctly discriminated pairs of phonemes

  3 months post- activation

• Speech discrimination: Number of correctly discriminated pairs of phonemes

  6 months post- activation

Other Outcomes (1)

• Evaluation of electrode contact location: Degrees of deviation

  8th months post activation

Study Arms (2)

ABF fitting followed by standard fitting

ACTIVE COMPARATOR

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

Standard fitting followed by ABF fitting

ACTIVE COMPARATOR

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

Interventions

Post-operative ABF followed by fitting according to clinical standard DEVICE

Cochlear implant will be fitted first with anatomy-based fitting for 6 months and followed by default fitting for 2 months.

ABF fitting followed by standard fitting

Fitting according to clinical standard followed by post-operative ABF DEVICE

Cochlear implant will be fitted first with default fitting for 6 months and followed by anatomy-based fitting for 2 months.

Standard fitting followed by ABF fitting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Subject is a Single-Sided Deafness (SSD) CI user
• Subject is an Electric Acoustic Stimulation (EAS) user (with an EAS audio processor)
• 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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel

Brussels, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Hearing Loss, 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

• Vedat Topsakal, Prof.

  UZB-VUB

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilie Heuninck

CONTACT

024749772; emilie.heuninck@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: May 11, 2022
• Study Start: March 1, 2022
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)