Cochlear Hearing LossNCT04815343
Investigation of the Naída CI M90 Sound Processor in Various Acoustic Scenarios
A study testing Naída CI M90 Sound Processor (hearing aid and cochlea implant sound processor) in people with Cochlear Hearing Loss, run by Advanced Bionics AG at 1 site in Germany.
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 Naída Link M90 hearing aid and Naída CI M90 sound processor on sound perception. 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?
- Naída CI M90 Sound Processor (hearing aid and cochlea implant sound processor)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 20 Nov 2020to 9 Aug 2021
- Phase
- Interventional
- 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
Who may be able to join
- CI users with a CII, HiRes90K (Advantage) or HiRes Ultra 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
Show all 9Show fewer
- Ability to give feedback on sound quality
- Speech intelligibility with the HSM sentence test in noise at 10 dB SNR > 10% as obtained during previous visits in the clinical routine
- Fluent in German language
Who cannot join
- Difficulties additional to hearing impairment that would interfere with the study procedures
- Concurrent participation in other study
- Pregnant and breast-feeding women
Trial locations and contacts
1 site in 1 country.
Germany1 site
Medizinische Hochschule Hannover (MHH)
Hanover, Lower Saxony, 30625
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 Naída Link M90 hearing aid and Naída CI M90 sound processor 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 that uses the investigational device is not large in general.
- Conditions
- Cochlear Hearing Loss
- Being tested
- Naída CI M90 Sound Processor (hearing aid and cochlea implant sound processor)
- 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.
Naída CI M90 Sound Processor (hearing aid and cochlea implant sound processor)Device
Speech perception measures, Hearing thresholds, Enjoyment rating, Sound identification, Subjective feedback
| Study group | Role | What they receive |
|---|---|---|
| Bilateral users | Experimental | two implant systemswith two sound processors Receives: Device: Naída CI M90 Sound Processor (hearing aid and cochlea implant sound processor) |
| Bimodal user | Experimental | with one sound processor and one hearing aid Receives: Device: Naída CI M90 Sound Processor (hearing aid and cochlea implant sound processor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in speech perception in noise with AutoSense OS on Naída M hearing devices and AutoSound OS on the clinically available Naída Q hearing devices
Difference in speech reception threshold of 50% speech understanding which is the signal to noise ratio in Decibel [dB] to understand 50% of the target speech between AutoSense OS on Naída M hearing devices and AutoSound OS on the clinically available Naída Q hearing devices.
Measured: 6 weeks
Secondary outcomes (5)
Differences in speech perception in noise threshold measured in Decibel [dB]
Differences are compared between AutoSense OS on Naída M hearing devices and the omnidirectional microphone setting on Naída Q hearing devices.
Min and Max values are -10dB and +10dB, whereas the smalller the value the better
Measured: 6 weeks
Differences in speech perception in quiet threshold measured in Decibel [dB]
Differences are compared between AutoSense OS on Naída M hearing devices and AutoSound OS on Naída Q hearing devices and the omnidirectional microphone setting on Naída Q hearing devices.
Min and Max values are -10dB and +10dB, whereas the smalller the value the better
Measured: 6 weeks
Differences in mono/stereo identification measured in % correct
Differences are compared between mono and stereo free-field presentation, mono and stereo streaming presentation, stereo free-field and stereo streaming presentation, mono free-field and mono streaming presentation, differences in music enjoyment ratings measured in rating score
Measured: 6 weeks
Differences in speech understanding in noise measured in % correct
Differences are compared between AutoZoomControl on Naída M hearing devices and the omnidirectional microphone setting on Naída Q hearing devices
Measured: 6 weeks
Differences in music enjoyment ratings measured in rating score
Differences are compared between
- mono and stereo free-field presentation
- mono and stereo streaming presentation
- stereo free-field and stereo streaming presentation
- mono free-field and mono streaming presentation
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start20 Nov 2020
- Primary completion1 May 2021
- Study completion9 Aug 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- comparision of different conditions with-in subject. (10 bimodal, 10 bilateral CI users)
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Bionics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815343
- Sponsor's protocol ID
- ABIntl-20-04
- Status last verified
- Nov 2021
- First submitted
- 19 Mar 2021
- Last updated
- 24 Nov 2021
- 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 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Naída CI M90 Sound Processor in Various Acoustic Scenarios
- ClinicalTrials.gov ID
- NCT04815343
- Acronym / sponsor ID
- ABIntl-20-04
- Conditions
- Cochlear Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Advanced Bionics AGIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 9 Aug 2021 (actual)
- First posted
- 25 Mar 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.
In this clinical trial, an un-controlled, repeated measures open design with within-subject comparison will be used to evaluate the effect of Naída Link M90 hearing aid and Naída CI M90 sound processor 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 that uses the investigational device is not large in general.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- comparision of different conditions with-in subject. (10 bimodal, 10 bilateral CI users)
| Arm | Type | Receives |
|---|---|---|
| Bilateral users | Experimental | Device: Naída CI M90 Sound Processor (hearing aid and cochlea implant sound processor)two implant systemswith two sound processors |
| Bimodal user | Experimental | Device: Naída CI M90 Sound Processor (hearing aid and cochlea implant sound processor)with one sound processor and one hearing aid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- CI users with a CII, HiRes90K (Advantage) or HiRes Ultra implant system
- 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
Key exclusion criteria (3 listed)
- Difficulties additional to hearing impairment that would interfere with the study procedures
- Concurrent participation in other study
- Pregnant and breast-feeding women
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 |
|---|---|---|
| Naída CI M90 Sound Processor (hearing aid and cochlea implant sound processor)Speech perception measures, Hearing thresholds, Enjoyment rating, Sound identification, Subjective feedback | Device | Bilateral users, Bimodal user |
Primary outcome
Difference in speech perception in noise with AutoSense OS on Naída M hearing devices and AutoSound OS on the clinically available Naída Q hearing devices
Time frame: 6 weeks
Difference in speech reception threshold of 50% speech understanding which is the signal to noise ratio in Decibel [dB] to understand 50% of the target speech between AutoSense OS on Naída M hearing devices and AutoSound OS on the clinically available Naída Q hearing devices.
5 secondary outcomes
Differences in speech perception in noise threshold measured in Decibel [dB]
Time frame: 6 weeks
Differences in speech perception in quiet threshold measured in Decibel [dB]
Time frame: 6 weeks
Differences in mono/stereo identification measured in % correct
Time frame: 6 weeks
Differences in speech understanding in noise measured in % correct
Time frame: 6 weeks
Differences in music enjoyment ratings measured in rating score
Time frame: 6 weeks
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 24 Nov 2021.
- Individual participant dataSharing planned: No
Related trials for Cochlear Hearing Loss
RecruitingObservational study
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
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Retrospectively Investigating Longitudinal Outcomes in MED-EL SONATA 2 Cochlear Implant Recipients.
Cochlear Implantation, Sensorineural Hearing Loss
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Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants
Deafness
Not yet recruitingObservational study
Mi2000 TICI Follow-up
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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?
A study testing Naída CI M90 Sound Processor (hearing aid and cochlea implant sound processor) in people with Cochlear Hearing Loss, run by Advanced Bionics AG at 1 site in Germany.
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 24 Nov 2021. 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 Germany. 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 perception in noise with AutoSense OS on Naída M hearing devices and AutoSound OS on the clinically available Naída Q hearing devices (time frame: 6 weeks). 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 24 Nov 2021.