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

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05007886
• Other study ID #: 292396
• Status: Enrolling by invitation
• Start date: August 13, 2021
• Est. completion date: August 1, 2023

Study information

• Verified date: August 2021
• Source: Cambridge University Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: August 1, 2023
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cochlear Hearing Loss
• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural

Locations

Country	Name	City	State
United Kingdom	Cambridge Biomedical Campus, Addenbrookes Hospital	Cambridge

Sponsors (1)

Lead Sponsor	Collaborator
Cambridge University Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Differences in sound clarity and comfort with Naida M (Marvel) device when listening to speech	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