Remote Evaluation of the Naída CI M90 (Marvel) Sound Processor

• Conditions: Cochlear Hearing Loss; Hearing Loss

• Registration Number: NCT05007886
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief Summary

Within-subject comparison. Remotely Evaluating latest Advanced Bionics Marvel Sound Processor for cochlear implants, from two adult groups.

Detailed Description

Within-subject comparison, standard of care CE marked Advanced Bionics device. Remote Evaluation of new CI Naida M sound processor through speech understanding in quiet and noise using standard clinical tests, subjective feedback on sound quality for a set of listening situations reflecting everyday use and a ease of use questionnaire. Two adult groups, one CI users and the other bimodal users. All tests completed remotely.

Study Timeline

• Study First Submitted: 2021-07-28
• Status Verified: 2021-08
• Study Start: 2021-08-13
• Study First Submitted QC: 2021-08-16
• Study First Posted: 2021-08-17
• Last Update Submitted: 2021-08-18
• Last Update Posted: 2021-08-19
• Primary Completion: 2022-09-01
• Study Completion: 2023-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• CI users with a CI, HiRes90K (Advantage) or HiRes Ultra cochlear implant system

• Unilaterally implanted recipients using only a Naída Q sound processor

• Bimodal users: additionally using hearing aid on their contralateral ear

  • Minimum of 18 years of age
  • Minimum of five years' experience with their Naída Q sound processor
  • Minimum of six months experience with their contralateral hearing aid (if applicable)
  • Ability to give feedback on sound quality
  • Speech intelligibility with the BKB sentence test in noise at a +10 dB SNR > 10% as obtained during previous visits in the clinical routine or BKB >50% in quiet conditions if noise has previously not been tested
  • Fluent in English language

Exclusion Criteria

• Difficulties additional to hearing impairment that would interfere with the study procedures
• Concurrent participation in any other clinical hearing study
• Not due to have their sound processor upgraded in line with normal clinical procedures

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate difference in speech perception in noise with Naida M (Marvel) and Naida Q hearing devices	12 months	Understanding speech in presence of completing noise and quiet testing remotely through use of Gorilla software. This will be done through a percentage score calculated within the Gorilla software.

Secondary Outcome Measures

Name	Time	Method
Differences in sound clarity and comfort with Naida M (Marvel) device when listening to speech	12 months	Assessment in quiet, background, speech babble, household noises, traffic noise, cafeteria noise and louder alarm signals.This will be done through a measurement of specific questionnaires.

Trial Locations

Locations (1)

Cambridge Biomedical Campus, Addenbrookes Hospital; 🇬🇧 Cambridge, United Kingdom