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

Sponsor
Cambridge University Hospitals NHS Foundation Trust (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05007886
Collaborator
(none)
20
Enrollment
1
Location
23.6
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Remote Evaluation of the Naída CI M90 (Marvel) Sound Processor
    Actual Study Start Date :
    Aug 13, 2021
    Anticipated Primary Completion Date :
    Sep 1, 2022
    Anticipated Study Completion Date :
    Aug 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cambridge Biomedical Campus, Addenbrookes Hospital Cambridge United Kingdom CB2 OQQ

    Sponsors and Collaborators

    • Cambridge University Hospitals NHS Foundation Trust

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sophie McKenny, Clinical Researcher, Cambridge University Hospitals NHS Foundation Trust
    ClinicalTrials.gov Identifier:
    NCT05007886
    Other Study ID Numbers:
    • 292396
    First Posted:
    Aug 17, 2021
    Last Update Posted:
    Aug 19, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sophie McKenny, Clinical Researcher, Cambridge University Hospitals NHS Foundation Trust
    cochlear implant
    Advanced Bionics Marvel Processor
    Additional relevant MeSH terms:
    Hearing Loss
    Deafness
    Hearing Loss, Sensorineural

    Study Results

    No Results Posted as of Aug 19, 2021