Cochlear Hearing LossNCT04610216
Investigation of the Automatic Technology on the Naída M Hearing Devices
An observational study of Cochlear Hearing Loss, run by Advanced Bionics AG at 1 site in Switzerland.
Trial summary
In this clinical trial, an un-controlled, repeated measures open design with within-subject comparison will be used to evaluate the effect of the device under investigation on sound perception. This design was shown to be successful in previous studies for the evaluation of sound coding strategies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cochlear Hearing Loss
- What is being tested?
- Naida CI M hearing device
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Oct 2020to 23 Sep 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The intended users of the Naída M hearing system are people who suffer from profound sensorineural hearing losses up to complete deafness. The users could be recipients that are already users of an Advanced Bionics CI but also people who suffer from deafness or profound hearing loss and were not previously equipped with a hearing device. In case of contralateral acoustic hearing, the user might use a Naída CI M90 on the side with profound sensorineural hearing loss and a Naída Link M90 as a hearing aid on the contralateral side to aid the residual acoustic hearing.
Who may be able to join
- · CI users with a CII, HiRes90K (Advantage) or HiRes Ultra (3D) implant system Bilateral users: two implant systems Bimodal users: hearing aid contralateral
- Minimum of 18 years of age
- Minimum of six months experience with their implant system
- Minimum of six months experience with the Naída CI Q-Series sound processor
- Ability to give feedback on sound quality
- Speech reception thresholds of no more than 5 dB SNR > 10 at the French Matrix test obtained during previous visits in the clinical routine
- Fluent in French language
Who cannot join
- Difficulties additional to hearing impairment that would interfere with the study procedures
- Concurrent participation in other study
- Incapacity for consent
Trial locations and contacts
1 site in 1 country.
About this study
In this clinical trial, an un-controlled, repeated measures open design with within-subject comparison will be used to evaluate the effect of the device under investigation on sound perception. This design was shown to be successful in previous studies for the evaluation of sound coding strategies.
Furthermore, a within-subject comparison decreases the variance in the results allowing for fewer subjects when the population using the investigational device is not large in general.
Read the detailed description
The primary endpoint of this clinical investigation is the difference in speech intelligibility measured in percent correct with AutoZoomControl compared to an omnidirectional microphone on Naída M hearing devices.The Naída CI M90 sound processor is a behind-the-ear (BTE) sound processor based on the Phonak Marvel hearing aid platform. It replaces the market approved Naída CI Q-Series processors. The Naída Link M90 hearing aid is a behind-the-ear (BTE) hearing aid based on the Phonak Marvel hearing aid platform. It is especially designed to be used for bimodal CI users equipped with a Naída CI M90 sound processor.
- Conditions
- Cochlear Hearing Loss
- Being tested
- Naida CI M hearing device
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naida CI M hearing deviceDevice
speech intelligibility measurement with Naida CI M hearing device
| Study group | Role | What they receive |
|---|---|---|
| Bilateral users: two implant systems | For bilateral CI users two Naida CI M sound processors (one per ear) will be used during the study. Receives: Device: Naida CI M hearing device | |
| Bimodal users: hearing aid contralateral | For bimodal subjects there will be one Naida CI M sound processor on the implanted ear as well as one hearing aid on the contralateral ear. Receives: Device: Naida CI M hearing device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in speech intelligibility in noise
The primary endpoint of this clinical investigation is the difference in speech intelligibility measured in percent correct with AutoZoomControl compared to an omnidirectional microphone on Naída M hearing devices. The French Matrix Test will be used and percentage correct will be recorded.
Measured: 2 months
Secondary outcomes (2)
Differences in speech perception in noise
ZoomControl versus Omnidirectional microphone and AutoZoomControl versus ZoomControlon Naída M hearing devices will be compared.
The French Matrix Test will be used and percentage correct will be recorded.
Measured: 2 months
Differences in localization abilities
AutoZoom control versus Omnidirectional microphone, ZoomControl versus Omnidirectional microphone and AutoZoomControl versus ZoomControlon Naída M hearing devices will be compared.
The directions (0,+/-90,180 degrees) from where the sentences of the French Matrix Test are presented have to be determined.
Percentage correct will be recorded.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start20 Oct 2020
- Primary completion23 Sep 2021
- Study completion23 Sep 2021
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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Bionics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Angélica Pérez-Fornos, Dr, Principal investigator, angelica.perez-fornos@hcuge.ch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04610216
- Sponsor's protocol ID
- ABIntl-20-15
- Status last verified
- Mar 2021
- First submitted
- 7 Oct 2020
- Last updated
- 1 May 2024
- 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 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Automatic Technology on the Naída M Hearing Devices
- ClinicalTrials.gov ID
- NCT04610216
- Acronym / sponsor ID
- ABIntl-20-15
- Conditions
- Cochlear Hearing Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Advanced Bionics AGIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 23 Sep 2021 (actual)
- Study completion
- 23 Sep 2021 (actual)
- First posted
- 30 Oct 2020 (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.
In this clinical trial, an un-controlled, repeated measures open design with within-subject comparison will be used to evaluate the effect of the device under investigation on sound perception. This design was shown to be successful in previous studies for the evaluation of sound coding strategies.
Furthermore, a within-subject comparison decreases the variance in the results allowing for fewer subjects when the population using the investigational device is not large in general.
Detailed description
The primary endpoint of this clinical investigation is the difference in speech intelligibility measured in percent correct with AutoZoomControl compared to an omnidirectional microphone on Naída M hearing devices.The Naída CI M90 sound processor is a behind-the-ear (BTE) sound processor based on the Phonak Marvel hearing aid platform. It replaces the market approved Naída CI Q-Series processors. The Naída Link M90 hearing aid is a behind-the-ear (BTE) hearing aid based on the Phonak Marvel hearing aid platform. It is especially designed to be used for bimodal CI users equipped with a Naída CI M90 sound processor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bilateral users: two implant systems | – | Device: Naida CI M hearing deviceFor bilateral CI users two Naida CI M sound processors (one per ear) will be used during the study. |
| Bimodal users: hearing aid contralateral | – | Device: Naida CI M hearing deviceFor bimodal subjects there will be one Naida CI M sound processor on the implanted ear as well as one hearing aid on the contralateral ear. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The intended users of the Naída M hearing system are people who suffer from profound sensorineural hearing losses up to complete deafness. The users could be recipients that are already users of an Advanced Bionics CI but also people who suffer from deafness or profound hearing loss and were not previously equipped with a hearing device. In case of contralateral acoustic hearing, the user might use a Naída CI M90 on the side with profound sensorineural hearing loss and a Naída Link M90 as a hearing aid on the contralateral side to aid the residual acoustic hearing.
Key inclusion criteria (7 listed)
- · CI users with a CII, HiRes90K (Advantage) or HiRes Ultra (3D) implant system Bilateral users: two implant systems Bimodal users: hearing aid contralateral
Key exclusion criteria (3 listed)
- Difficulties additional to hearing impairment that would interfere with the study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naida CI M hearing devicespeech intelligibility measurement with Naida CI M hearing device | Device | Bilateral users: two implant systems, Bimodal users: hearing aid contralateral |
Primary outcome
Difference in speech intelligibility in noise
Time frame: 2 months
The primary endpoint of this clinical investigation is the difference in speech intelligibility measured in percent correct with AutoZoomControl compared to an omnidirectional microphone on Naída M hearing devices. The French Matrix Test will be used and percentage correct will be recorded.
2 secondary outcomes
Differences in speech perception in noise
Time frame: 2 months
Differences in localization abilities
Time frame: 2 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 1 May 2024.
- Individual participant dataSharing planned: No
Related trials for Cochlear Hearing Loss
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Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
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Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants
Deafness
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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.
Angélica Pérez-Fornos, Dr principal investigator
angelica.perez-fornos@hcuge.ch
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, run by Advanced Bionics AG at 1 site in Switzerland.
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 7 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 1 May 2024. 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 Switzerland. 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?
Difference in speech intelligibility in noise (time frame: 2 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 1 May 2024.