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

August 18, 2021 updated by: Sophie McKenny, Cambridge University Hospitals NHS Foundation Trust
Within-subject comparison. Remotely Evaluating latest Advanced Bionics Marvel Sound Processor for cochlear implants, from two adult groups.

Study Overview

Status

Enrolling by invitation

Conditions

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 Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Cambridge, United Kingdom, CB2 OQQ
        • Cambridge Biomedical Campus, Addenbrookes Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult Advanced Bionics cochlear implant users due for a sound processor upgrade in line with normal standard of care. Able to access the internet and undertake tests remotely.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate difference in speech perception in noise with Naida M (Marvel) and Naida Q hearing devices
Time Frame: 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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in sound clarity and comfort with Naida M (Marvel) device when listening to speech
Time Frame: 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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 13, 2021

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

July 28, 2021

First Submitted That Met QC Criteria

August 16, 2021

First Posted (Actual)

August 17, 2021

Study Record Updates

Last Update Posted (Actual)

August 19, 2021

Last Update Submitted That Met QC Criteria

August 18, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 292396

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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