Hearing Loss, ConductiveNCT03333577
Evaluation of the Baha SoundArc in Pediatric Patients
A study testing SoundArc in people with Hearing Loss, Conductive and Hearing Loss, Mixed, run by Cochlear at 3 sites in United States.
Trial summary
The purpose of this study is to gather clinical performance data on the Baha SoundArc Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Hearing Loss, Conductive, Hearing Loss, Mixed, Hearing Loss, Unilateral
- What is being tested?
- SoundArc
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Nov 2017to 2 Nov 2018
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Inclusion Criteria:• Existing recipients using a Baha sound processor on a Softband for at least three months
- Subjects aged 5 through 12 years of age
- Subjects should be able to perform clinical testing adapted for age and developmental status, (Threshold sound field audiometry and basic monosyllabic word test, PBK)
- Willingness on behalf of the subject's parent or guardian to complete study questionnaire
Exclusion Criteria:• Subject's inability to perform requisite test measures as described in the study protocol
-
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Arizona Hearing and Balance
Chandler, Arizona, 85224
Cook Children's Hospital
Fort Worth, Texas, 76104
Rady Children's Hospital
San Diego, California, 92123
About this study
The purpose of this study is to gather clinical performance data on the Baha SoundArc
Read the detailed description
Current Baha recipients that are using a Baha SoftBand will be recruited to be fitted with an alternative non-surgical option for using their Baha Sound Processor. The subjects will be tested with there existing Baha Sound Processor on the SoftBand and will then be fitted with the Baha SoundArc where they will perform a one month take home trial. At the end of this trial, the subject will return for testing and evaluation of their experience with this new fitting option.
- Being tested
- SoundArc
- Medical subject headings
- Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural, Hearing Loss, Unilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SoundArcDevice
non-surgical attachment method for wearing a bone conduction hearing system
| Study group | Role | What they receive |
|---|---|---|
| Experimental SoundArc study group | Experimental | all subjects will receive the SoundArc intervention Receives: Device: SoundArc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction Survey
To evaluate patient experience when using the Baha SoundArc after a one month take-home trial, compared to the existing Baha Softband on the Participant Take Home questionnaire (strongly agree, Agree, Neutral, disagree, strongly disagree)
Measured: one month post fitting
Percentage Correct on Word Identification Task
one list of monosyllabic words (PBK words) was assessed at 60dBA, with word scores recorded as a percent correct.
Measured: 4 weeks post fitting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start2 Nov 2017
- Primary completion2 Nov 2018
- Study completion2 Nov 2018
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hearing Loss, ConductiveStudies of the same condition, open and under way.
- More trials run by CochlearThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- George Cire, Study director, Study Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03333577
- Sponsor's protocol ID
- CAM5714
- Status last verified
- Apr 2019
- First submitted
- 2 Nov 2017
- Last updated
- 30 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Moyer C, Purdy J, Carvalho D, Vaughan L, Shroyer L. Evaluation of the Baha SoundArc in children. Int J Pediatr Otorhinolaryngol. 2024 Apr;179:111925. doi: 10.1016/j.ijporl.2024.111925. Epub 2024 Mar 27.
PubMed 38552429
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Baha SoundArc in Pediatric Patients
- ClinicalTrials.gov ID
- NCT03333577
- Acronym / sponsor ID
- CAM5714
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2017 (actual)
- Primary completion
- 2 Nov 2018 (actual)
- Study completion
- 2 Nov 2018 (actual)
- First posted
- 7 Nov 2017 (actual)
- Results
- Posted 11 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to gather clinical performance data on the Baha SoundArc
Detailed description
Current Baha recipients that are using a Baha SoftBand will be recruited to be fitted with an alternative non-surgical option for using their Baha Sound Processor. The subjects will be tested with there existing Baha Sound Processor on the SoftBand and will then be fitted with the Baha SoundArc where they will perform a one month take home trial. At the end of this trial, the subject will return for testing and evaluation of their experience with this new fitting option.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental SoundArc study group | Experimental | Device: SoundArcall subjects will receive the SoundArc intervention |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| SoundArcnon-surgical attachment method for wearing a bone conduction hearing system | Device | Experimental SoundArc study group |
Primary outcome
Patient Satisfaction Survey
Time frame: one month post fitting
To evaluate patient experience when using the Baha SoundArc after a one month take-home trial, compared to the existing Baha Softband on the Participant Take Home questionnaire (strongly agree, Agree, Neutral, disagree, strongly disagree)
Percentage Correct on Word Identification Task
Time frame: 4 weeks post fitting
one list of monosyllabic words (PBK words) was assessed at 60dBA, with word scores recorded as a percent correct.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38552429Moyer C, Purdy J, Carvalho D, Vaughan L, Shroyer L. Evaluation of the Baha SoundArc in children. Int J Pediatr Otorhinolaryngol. 2024 Apr;179:111925. doi: 10.1016/j.ijporl.2024.111925. Epub 2024 Mar 27.
- 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.
George Cire study director
Study Director
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SoundArc in people with Hearing Loss, Conductive and Hearing Loss, Mixed, run by Cochlear at 3 sites 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?
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 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 11 Apr 2019). 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?
Patient Satisfaction Survey (time frame: one month post fitting). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03333577, which also lists 1 linked publication.
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 30 Apr 2019.