Single Sided DeafnessPhase 4NCT01933386
Evaluation of Benefit for Treatment of Single Sided Deafness (SSD) Between Two Bone Conduction Prosthetic Devices; Osseointegrated Implant Versus Maxilla Anchored Removable Oral Appliance ("SoundBite")
A Phase 4 study testing SoundBite in people with Single Sided Deafness, run by Sonitus Medical Inc at 3 sites in United States.
Trial summary
The primary objective of this study is to compare the SoundBite™ Hearing System to surgically implanted BCD systems. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Single Sided Deafness
- What is being tested?
- SoundBite
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2013to Feb 2014
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be current users of a surgically implanted digitally programmable surgically implanted bone conduction device
- Must be >18, <80 years old
- Must be fluent in English, as determined by the PI
- Must have diagnosis of SSD, time since onset (≥3 months)
- Must have at least two contiguous molar or premolar teeth with no untreated tooth decay. Patients with tooth decay present are to first have restorations before being fitted for SoundBite
- Healthy attachment to those teeth with tooth pockets limited to no more than 5mm
Who cannot join
- Subjects with known hypersensitivity to any of the components including allergies to polymers.
- Subjects that are unable to use their hands such as quadriplegics or others that are unable to comply with the warnings in the product's labeling.
- Subjects with known or active secondary medical conditions associated with variable sensorineural hearing loss
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Michigan Ear Institute
Novi, Michigan, 48374
Jennifer Monitz, 248-465-4828, Jennifer.Monitz@providence-stjohnhealth.org
Robert Hong, M.D., Ph.D.
Arizona Ear Center
Phoenix, Arizona, 85004
Kelly Hernanadez, AuD, 602-307-9919, audiology@arizonaear.com
Mark Syms, MD
Ear Medical Group
San Antonio, Texas, 78240
Robyn Shanley, AuD, PhD, 210-614-6070, RobynS@earmedicalgroup.com
Charles Syms, MD
About this study
The primary objective of this study is to compare the SoundBite™ Hearing System to surgically implanted BCD systems.
- Conditions
- Single Sided Deafness
- Being tested
- SoundBite
- Keywords
- Single Sided Deafness, SSD, Unilateral hearing loss
- Medical subject headings
- Hearing Loss, Unilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SoundBiteDevice
Also called The SoundBite Hearing System
Non-surgical removable bone conduction device via the teeth.
| Study group | Role | What they receive |
|---|---|---|
| SoundBite | Other | SoundBite will be used for the first 30 days Receives: Device: SoundBite |
| Surgically Implanted BCD | Other | The subject's own surgically implanted bone conduction device will be used for the first 30 days. Receives: Device: SoundBite |
What is being measured
The primary outcome is the main question the study is designed to answer.
APHAB Questionnaire
Comparison of the SoundBite™ System and surgically implanted bone conduction devices
Measured: 30 days
Secondary outcomes (1)
Single Sided Deafness Questionnaire
Comparison of the SoundBite™ System and surgically implanted BCD systems.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionFeb 2014 (estimated)
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Single Sided DeafnessStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sonitus Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles Syms, MD, Principal investigator, Ear Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01933386
- Sponsor's protocol ID
- CLN008
- Status last verified
- Oct 2013
- First submitted
- 28 Aug 2013
- Last updated
- 29 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Benefit for Treatment of Single Sided Deafness (SSD) Between Two Bone Conduction Prosthetic Devices; Osseointegrated Implant Versus Maxilla Anchored Removable Oral Appliance ("SoundBite")
- ClinicalTrials.gov ID
- NCT01933386
- Acronym / sponsor ID
- CLN008
- Conditions
- Single Sided Deafness
- Keywords
- Single Sided Deafness, SSD, Unilateral hearing loss
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Sonitus Medical IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 2 Sep 2013 (estimated)
- 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 compare the SoundBite™ Hearing System to surgically implanted BCD systems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SoundBite | Other | Device: SoundBiteSoundBite will be used for the first 30 days |
| Surgically Implanted BCD | Other | Device: SoundBiteThe subject's own surgically implanted bone conduction device will be used for the first 30 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must be current users of a surgically implanted digitally programmable surgically implanted bone conduction device
- Must be >18, <80 years old
- Must be fluent in English, as determined by the PI
- Must have diagnosis of SSD, time since onset (≥3 months)
- Must have at least two contiguous molar or premolar teeth with no untreated tooth decay. Patients with tooth decay present are to first have restorations before being fitted for SoundBite
Key exclusion criteria (3 listed)
- Subjects with known hypersensitivity to any of the components including allergies to polymers.
- Subjects that are unable to use their hands such as quadriplegics or others that are unable to comply with the warnings in the product's labeling.
- Subjects with known or active secondary medical conditions associated with variable sensorineural hearing loss
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 |
|---|---|---|
| SoundBiteAlso: The SoundBite Hearing SystemNon-surgical removable bone conduction device via the teeth. | Device | SoundBite, Surgically Implanted BCD |
Primary outcome
APHAB Questionnaire
Time frame: 30 days
Comparison of the SoundBite™ System and surgically implanted bone conduction devices
1 secondary outcome
Single Sided Deafness Questionnaire
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2013.
- SoundBite Hearing SystemLink provided by the sponsor.
Related trials for Single Sided Deafness
RecruitingObservational study
Audiological Rehabilitation of Children With Unilateral Hearing Loss
Unilateral Hearing Loss
Enrolling by invitationObservational study
Post-Market Registry Study for Vibrant Hearing Solutions
Conductive Hearing Loss, Mixed Hearing Loss
Active, not recruiting
Single-Sided Deafness and Asymmetric Hearing Loss
Hearing Loss, Unilateral, Hearing Loss, Sensorineural
Active, not recruiting
Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness
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Active, not recruiting
Pediatric Expansion Study of the Sentio System
Hearing Loss, Conductive, Hearing Loss, Mixed
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.
Charles Syms, MD principal investigator
Ear Medical Group
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SoundBite in people with Single Sided Deafness, run by Sonitus Medical Inc 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?
The sponsor lists 6 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: status not confirmed, as of the sponsor's last update on 29 Oct 2013. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Linda Galow, M.S. (1-650-581-5094, linda@sonitusmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
APHAB Questionnaire (time frame: 30 days). 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 Oct 2013.