Hearing LossNCT05488535
Non-significant Risk Study of a Cochlear Implant Headpiece
A study testing cochlear implant headpiece in people with Hearing Loss and Sensorineural Hearing Loss, run by Advanced Bionics at 1 site in United States.
Trial summary
This study aims to evaluate a cochlear implant headpiece. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hearing Loss, Sensorineural Hearing Loss
- What is being tested?
- cochlear implant headpiece
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2019to 22 Feb 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pre- or post-lingually deafened.
- Fluent in English, French, or Spanish or capable of communication with a caregiver who is providing consent.
- Adult or child implanted with a commercially available Advanced Bionics cochlear implant. Children and adult participants are included to ensure device retention is appropriate for all implant populations.
- Have (or caregivers have) the cognitive and functional capability to comply with all directions during the study
- Be able to remove their own headpiece
- Have (or caregivers have) the cognitive and functional capability to complete the questionnaire required for the study
- Capable (or caregivers are capable) of reading and understanding patient information materials and giving written informed consent
Who cannot join
- Have any significant medical condition that, in the opinion of any of the investigators, is likely to interfere with study procedures or likely to confound evaluation of study data.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate a cochlear implant headpiece.
Read the detailed description
The headpiece and magnet are expected to provide acceptable comfort and retention for existing cochlear implant users. In this study participants will report on their experience with the investigational headpiece during daily life.
- Conditions
- Hearing Loss, Sensorineural Hearing Loss
- Being tested
- cochlear implant headpiece
- Keywords
- cochlear implant
- Medical subject headings
- Hearing Loss, Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cochlear implant headpieceDevice
investigational cochlear implant headpiece
| Study group | Role | What they receive |
|---|---|---|
| Non-significant risk study of a cochlear implant headpiece | Experimental | This arm aims to evaluate a cochlear implant headpiece. Receives: Device: cochlear implant headpiece |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Report of Headpiece Comfort and Retention
Comfort and subjective retention of the headpiece were rated via questionnaire for baseline headpiece and investigational headpiece acute and chronic use. Subjects were provided with ratings questionnaires and asked to chronically evaluate the headpiece and associated magnet for comfort and retention every two months. Results are presented as total count of participants who rated retention and comfort as favorable ("no opinion," "acceptable," or "very acceptable") at study close out.
The baseline/investigational headpiece questionnaires included 2 questions:
- Rate the retention of your personal/investigational headpiece (Very acceptable, Acceptable, No Opinion, Unacceptable, Very Unacceptable)
- Rate the comfort of your personal headpiece (Very acceptable, Acceptable, No Opinion, Unacceptable, Very Unacceptable)
Measured: Assessed every two months from month 2 to month 12, values at study close out (month 12) reported.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start28 Feb 2019
- Primary completion22 Feb 2020
- Study completion22 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Bionics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488535
- Sponsor's protocol ID
- 20190256
- Status last verified
- Aug 2023
- First submitted
- 26 Jul 2022
- Last updated
- 14 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-significant Risk Study of a Cochlear Implant Headpiece
- ClinicalTrials.gov ID
- NCT05488535
- Acronym / sponsor ID
- 20190256
- Conditions
- Hearing Loss, Sensorineural Hearing Loss
- Keywords
- cochlear implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Advanced BionicsIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 22 Feb 2020 (actual)
- Study completion
- 22 Feb 2020 (actual)
- First posted
- 4 Aug 2022 (actual)
- Results
- Posted 14 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate a cochlear implant headpiece.
Detailed description
The headpiece and magnet are expected to provide acceptable comfort and retention for existing cochlear implant users. In this study participants will report on their experience with the investigational headpiece during daily life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-significant risk study of a cochlear implant headpiece | Experimental | Device: cochlear implant headpieceThis arm aims to evaluate a cochlear implant headpiece. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Pre- or post-lingually deafened.
- Fluent in English, French, or Spanish or capable of communication with a caregiver who is providing consent.
- Adult or child implanted with a commercially available Advanced Bionics cochlear implant. Children and adult participants are included to ensure device retention is appropriate for all implant populations.
- Have (or caregivers have) the cognitive and functional capability to comply with all directions during the study
- Be able to remove their own headpiece
Key exclusion criteria (1 listed)
- Have any significant medical condition that, in the opinion of any of the investigators, is likely to interfere with study procedures or likely to confound evaluation of study data.
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 |
|---|---|---|
| cochlear implant headpieceinvestigational cochlear implant headpiece | Device | Non-significant risk study of a cochlear implant headpiece |
Primary outcome
Subjective Report of Headpiece Comfort and Retention
Time frame: Assessed every two months from month 2 to month 12, values at study close out (month 12) reported.
Comfort and subjective retention of the headpiece were rated via questionnaire for baseline headpiece and investigational headpiece acute and chronic use. Subjects were provided with ratings questionnaires and asked to chronically evaluate the headpiece and associated magnet for comfort and retention every two months. Results are presented as total count of participants who rated retention and comfort as favorable ("no opinion," "acceptable," or "very acceptable") at study close out. The baseline/investigational headpiece questionnaires included 2 questions: 1. Rate the retention of your personal/investigational headpiece (Very acceptable, Acceptable, No Opinion, Unacceptable, Very Unacceptable) 2. Rate the comfort of your personal headpiece (Very acceptable, Acceptable, No Opinion, Unacceptable, Very Unacceptable)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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?
A study testing cochlear implant headpiece in people with Hearing Loss and Sensorineural Hearing Loss, run by Advanced Bionics 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 7 inclusion and 1 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 14 Nov 2023. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Subjective Report of Headpiece Comfort and Retention (time frame: Assessed every two months from month 2 to month 12, values at study close out (month 12) reported.). 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 14 Nov 2023.