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

NCT05007886 | Unknown

• 1 other identifier: 292396
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cochlear Hearing Loss; Hearing Loss

Keywords

cochlear implant; Advanced Bionics Marvel Processor

Outcome Measures

Primary Outcomes (1)

• Evaluate difference in speech perception in noise with Naida M (Marvel) and Naida Q hearing devices

  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 Outcomes (1)

• Differences in sound clarity and comfort with Naida M (Marvel) device when listening to speech

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead

Study Sites (1)

Cambridge Biomedical Campus, Addenbrookes Hospital

Cambridge, CB2 OQQ, United Kingdom

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural; Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Researcher

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: August 17, 2021
• Study Start: August 13, 2021
• Primary Completion: September 1, 2022
• Study Completion: August 1, 2023
• Last Updated: August 19, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)