Cochlear Hearing LossNCT05007886
Remote Evaluation of the Naída CI M90 (Marvel) Sound Processor
An observational study of Cochlear Hearing Loss and Hearing Loss, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Within-subject comparison. Remotely Evaluating latest Advanced Bionics Marvel Sound Processor for cochlear implants, from two adult groups. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cochlear Hearing Loss, Hearing Loss
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Aug 2021to 1 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cambridge Biomedical Campus, Addenbrookes Hospital
Cambridge, CB2 OQQ
About this study
Within-subject comparison. Remotely Evaluating latest Advanced Bionics Marvel Sound Processor for cochlear implants, from two adult groups.
Read the 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.
- Conditions
- Cochlear Hearing Loss, Hearing Loss
- Keywords
- cochlear implant, Advanced Bionics Marvel Processor
- Medical subject headings
- Hearing Loss, Sensorineural, Hearing Loss
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start13 Aug 2021
- Primary completion1 Sep 2022
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sophie McKenny, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05007886
- Sponsor's protocol ID
- 292396
- Status last verified
- Nov 2026
- First submitted
- 28 Jul 2021
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Evaluation of the Naída CI M90 (Marvel) Sound Processor
- ClinicalTrials.gov ID
- NCT05007886
- Acronym / sponsor ID
- 292396
- Conditions
- Cochlear Hearing Loss, Hearing Loss
- Keywords
- cochlear implant, Advanced Bionics Marvel Processor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 13 Aug 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 17 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Differences in sound clarity and comfort with Naida M (Marvel) device when listening to speech
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cochlear Hearing Loss and Hearing Loss, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate difference in speech perception in noise with Naida M (Marvel) and Naida Q hearing devices (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.