Cochlear ImplantPhase 4NCT04041596
Degree of Benefit From Low-Frequency Acoustic Amplification Using the Advanced Bionics Acoustic Earhook
A Phase 4 study testing Advanced Bionics' Acoustic Earhook in people with Cochlear Implant and Cochlear Hearing Loss, run by NYU Langone Health at 1 site in United States.
Trial summary
The primary objective of this study is to obtain a greater understanding of the range in benefit from acoustic amplification combined with electric stimulation in cochlear implant recipients with low-frequency hearing who do not currently use the commercially approved Advanced Bionics Acoustic Earhook. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cochlear Implant, Cochlear Hearing Loss
- What is being tested?
- Advanced Bionics' Acoustic Earhook
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2018to 17 Mar 2020
- Phase
- Phase 4
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to provide informed consent
- Implanted with an Advanced Bionics Advanced Bionics HiRes Ultra, 90K, or CII implant, and using a Naída Q90 sound processor
- 18 years of age or older with post-lingual hearing loss
- Aided open-set speech recognition scores greater than 30% correct in quiet in the ear to be tested
- Unaided low frequency audiometric hearing thresholds of 90 dB HL or better at .125, .25, and .5 kHz
- Participants must have a working understanding of and ability to verbalize in English as the evaluation measures are available exclusively in English
- Willingness to use an acoustic component with their ear-level sound processor postoperatively for the duration of the study
- Willingness to participate in all scheduled procedures outlined in the protocol
Who cannot join
- Exclusive use of a body worn external sound processor
- Deafness due to central auditory lesion or cochlear nerve deficiency, diagnosis of auditory neuropathy/dys-synchrony in either the implanted or the contralateral ear
- Postoperative unaided low frequency audiometric hearing thresholds in the implanted ear exceeding 90 dB HL at any frequency from 125 - 500 Hz.
- Presence of other conditions that could affect performance on outcome measures or otherwise confound or interfere with study participation or outcomes measures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IV, Single-center Study of the Benefits of the Advanced Bionics Naída CI Q90 Acoustic Earhook in Adults Cochlear Implant Recipients.
The primary objective of this study is to obtain a greater understanding of the range in benefit from acoustic amplification combined with electric stimulation in cochlear implant recipients with low-frequency hearing who do not currently use the commercially approved Advanced Bionics Acoustic Earhook. The aims of this study are to 1) obtain subjective sound quality judgements of recorded speech and music samples, 2) assess vocal emotion perception, and 3) evaluate post-operative speech perception and sound field detection thresholds in CI recipients both with and without use of the acoustic ear hook.
- Conditions
- Cochlear Implant, Cochlear Hearing Loss
- Being tested
- Advanced Bionics' Acoustic Earhook
- 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.
Advanced Bionics' Acoustic EarhookDevice
designed to deliver acoustic amplification through the modular attachment of the Naída CI Q90 AcoustiEarhook, while also delivering electrical stimulation along the full range of the implanted Advanced Bionics electrode.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Speech recognition testing, with and without acoustic earhook
5-alternative identification task to measure vocal emotion recognition (Toronto Emotional Speech Test (TESS) at initial fitting, and 3, 6, and 12 months after fitting
Measured: 3 Months, 6 Months, 12 Months
Change in Sound quality judgements, with and without acoustic earhook
Ratings of sound quality (Judgement of Sound Quality {JSQ} test) of speech and music samples at initial fitting, and 3, 6, and 12 months after fitting
Measured: 3 Months, 6 Months, 12 Months
Change in Vocal emotion perception task, with and without acoustic earhook
Measured: 3 Months, 6 Months, 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start18 Sep 2018
- Primary completion17 Mar 2020
- Study completion17 Mar 2020
Why it stopped: Due to a lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear ImplantStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Waltzman, MD, Principal investigator, New York Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04041596
- Sponsor's protocol ID
- 18-01276
- Status last verified
- May 2020
- First submitted
- 30 Jul 2019
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Single-center Study of the Benefits of the Advanced Bionics Naída CI Q90 Acoustic Earhook in Adults Cochlear Implant Recipients.
- ClinicalTrials.gov ID
- NCT04041596
- Acronym / sponsor ID
- 18-01276
- Conditions
- Cochlear Implant, Cochlear Hearing Loss
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to a lack of enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 18 Sep 2018 (actual)
- Primary completion
- 17 Mar 2020 (actual)
- Study completion
- 17 Mar 2020 (actual)
- First posted
- 1 Aug 2019 (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.
The primary objective of this study is to obtain a greater understanding of the range in benefit from acoustic amplification combined with electric stimulation in cochlear implant recipients with low-frequency hearing who do not currently use the commercially approved Advanced Bionics Acoustic Earhook. The aims of this study are to 1) obtain subjective sound quality judgements of recorded speech and music samples, 2) assess vocal emotion perception, and 3) evaluate post-operative speech perception and sound field detection thresholds in CI recipients both with and without use of the acoustic ear hook.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ability to provide informed consent
- Implanted with an Advanced Bionics Advanced Bionics HiRes Ultra, 90K, or CII implant, and using a Naída Q90 sound processor
- 18 years of age or older with post-lingual hearing loss
- Aided open-set speech recognition scores greater than 30% correct in quiet in the ear to be tested
- Unaided low frequency audiometric hearing thresholds of 90 dB HL or better at .125, .25, and .5 kHz
Key exclusion criteria (4 listed)
- Exclusive use of a body worn external sound processor
- Deafness due to central auditory lesion or cochlear nerve deficiency, diagnosis of auditory neuropathy/dys-synchrony in either the implanted or the contralateral ear
- Postoperative unaided low frequency audiometric hearing thresholds in the implanted ear exceeding 90 dB HL at any frequency from 125 - 500 Hz.
- Presence of other conditions that could affect performance on outcome measures or otherwise confound or interfere with study participation or outcomes measures.
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 |
|---|---|---|
| Advanced Bionics' Acoustic Earhookdesigned to deliver acoustic amplification through the modular attachment of the Naída CI Q90 AcoustiEarhook, while also delivering electrical stimulation along the full range of the implanted Advanced Bionics electrode. | Device | – |
Primary outcome
Change in Speech recognition testing, with and without acoustic earhook
Time frame: 3 Months, 6 Months, 12 Months
5-alternative identification task to measure vocal emotion recognition (Toronto Emotional Speech Test (TESS) at initial fitting, and 3, 6, and 12 months after fitting
Change in Sound quality judgements, with and without acoustic earhook
Time frame: 3 Months, 6 Months, 12 Months
Ratings of sound quality (Judgement of Sound Quality {JSQ} test) of speech and music samples at initial fitting, and 3, 6, and 12 months after fitting
Change in Vocal emotion perception task, with and without acoustic earhook
Time frame: 3 Months, 6 Months, 12 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
- Individual participant dataSharing planned: No
Related trials for Cochlear Implant
RecruitingObservational study
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
Cochlear Hearing Loss
RecruitingObservational study
Retrospectively Investigating Longitudinal Outcomes in MED-EL SONATA 2 Cochlear Implant Recipients.
Cochlear Implantation, Sensorineural Hearing Loss
Recruiting
Cochlear Implants and Listening Effort: the Interaction of Cognitive and Sensory Constraints
Cochlear Implant Users
Recruiting
Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants
Deafness
Not yet recruitingObservational study
Mi2000 TICI Follow-up
Hearing Loss, Binaural, Cochlear Implantation
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.
Susan Waltzman, MD principal investigator
New York Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Advanced Bionics' Acoustic Earhook in people with Cochlear Implant and Cochlear Hearing Loss, run by NYU Langone Health at 1 site in United States.
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 8 inclusion and 4 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: withdrawn, as of the sponsor's last update on 29 May 2020. 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 States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in Speech recognition testing, with and without acoustic earhook (time frame: 3 Months, 6 Months, 12 Months). The study lists 3 primary outcomes in all. 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 29 May 2020.