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")
October 25, 2013 updated by: Sonitus Medical Inc
The primary objective of this study is to compare the SoundBite™ Hearing System to surgically implanted BCD systems.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
15
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85004
- Arizona Ear Center
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Michigan
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Novi, Michigan, United States, 48374
- Michigan Ear Institute
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Texas
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San Antonio, Texas, United States, 78240
- Ear Medical Group
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: SoundBite
SoundBite will be used for the first 30 days
|
Non-surgical removable bone conduction device via the teeth.
Other Names:
|
|
Other: Surgically Implanted BCD
The subject's own surgically implanted bone conduction device will be used for the first 30 days.
|
Non-surgical removable bone conduction device via the teeth.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
APHAB Questionnaire
Time Frame: 30 days
|
Comparison of the SoundBite™ System and surgically implanted bone conduction devices
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Single Sided Deafness Questionnaire
Time Frame: 30 days
|
Comparison of the SoundBite™ System and surgically implanted BCD systems.
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Anticipated)
February 1, 2014
Study Completion (Anticipated)
February 1, 2014
Study Registration Dates
First Submitted
August 28, 2013
First Submitted That Met QC Criteria
August 30, 2013
First Posted (Estimate)
September 2, 2013
Study Record Updates
Last Update Posted (Estimate)
October 29, 2013
Last Update Submitted That Met QC Criteria
October 25, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLN008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.