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

NCT ID: NCT05007886

Last Updated: 2021-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-13

Study Completion Date

2023-08-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Cochlear Hearing Loss Hearing Loss

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cambridge University Hospitals NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Sophie McKenny

Clinical Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cambridge Biomedical Campus, Addenbrookes Hospital

Cambridge, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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292396

Identifier Type: -

Identifier Source: org_study_id

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