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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05007886
Enrollment
20
Registered
2021-08-17
Start date
2021-08-13
Completion date
2023-08-01
Last updated
2021-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cochlear Hearing Loss, Hearing Loss

Keywords

cochlear implant, Advanced Bionics Marvel Processor

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.

Interventions

None listed

Sponsors

Cambridge University Hospitals NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Evaluate difference in speech perception in noise with Naida M (Marvel) and Naida Q hearing devices12 monthsUnderstanding 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

MeasureTime frameDescription
Differences in sound clarity and comfort with Naida M (Marvel) device when listening to speech12 monthsAssessment 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.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026