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")
NCT ID: NCT01933386
Last Updated: 2013-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
15 participants
INTERVENTIONAL
2013-09-30
2014-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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SoundBite
SoundBite will be used for the first 30 days
SoundBite
Non-surgical removable bone conduction device via the teeth.
Surgically Implanted BCD
The subject's own surgically implanted bone conduction device will be used for the first 30 days.
SoundBite
Non-surgical removable bone conduction device via the teeth.
Interventions
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SoundBite
Non-surgical removable bone conduction device via the teeth.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
80 Years
ALL
No
Sponsors
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Sonitus Medical Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Charles Syms, MD
Role: PRINCIPAL_INVESTIGATOR
Ear Medical Group
Locations
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Arizona Ear Center
Phoenix, Arizona, United States
Michigan Ear Institute
Novi, Michigan, United States
Ear Medical Group
San Antonio, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Kelly Hernanadez, AuD
Role: primary
Jennifer Monitz
Role: primary
Robyn Shanley, AuD, PhD
Role: primary
Related Links
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SoundBite Hearing System
Other Identifiers
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CLN008
Identifier Type: -
Identifier Source: org_study_id