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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")

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ClinicalTrials.gov Identifier: NCT01933386
Recruitment Status : Unknown
Verified October 2013 by Sonitus Medical Inc.
Recruitment status was:  Not yet recruiting
First Posted : September 2, 2013
Last Update Posted : October 29, 2013
Sponsor:
Information provided by (Responsible Party):
Sonitus Medical Inc

Study Description
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Brief Summary:
The primary objective of this study is to compare the SoundBite™ Hearing System to surgically implanted BCD systems.

Condition or disease Intervention/treatment Phase
Single Sided Deafness Device: SoundBite Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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")
Study Start Date : September 2013
Estimated Primary Completion Date : February 2014
Estimated Study Completion Date : February 2014

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Arms and Interventions
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Arm Intervention/treatment
SoundBite
SoundBite will be used for the first 30 days
 Device: SoundBite
Non-surgical removable bone conduction device via the teeth.
Other Name: The SoundBite Hearing System
Surgically Implanted BCD
The subject's own surgically implanted bone conduction device will be used for the first 30 days.
 Device: SoundBite
Non-surgical removable bone conduction device via the teeth.
Other Name: The SoundBite Hearing System


Outcome Measures
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Primary Outcome Measures :
  1. APHAB Questionnaire [ Time Frame: 30 days ]
    Comparison of the SoundBite™ System and surgically implanted bone conduction devices


Secondary Outcome Measures :
  1. Single Sided Deafness Questionnaire [ Time Frame: 30 days ]
    Comparison of the SoundBite™ System and surgically implanted BCD systems.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01933386


Contacts
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Contact: Linda Galow, M.S. 1-650-581-5094 linda@sonitusmedical.com

Locations
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United States, Arizona
Arizona Ear Center
Phoenix, Arizona, United States, 85004
Contact: Kelly Hernanadez, AuD    602-307-9919    audiology@arizonaear.com   
Principal Investigator: Mark Syms, MD         
United States, Michigan
Michigan Ear Institute
Novi, Michigan, United States, 48374
Contact: Jennifer Monitz    248-465-4828    Jennifer.Monitz@providence-stjohnhealth.org   
Principal Investigator: Robert Hong, M.D., Ph.D.         
United States, Texas
Ear Medical Group
San Antonio, Texas, United States, 78240
Contact: Robyn Shanley, AuD, PhD    210-614-6070    RobynS@earmedicalgroup.com   
Principal Investigator: Charles Syms, MD         
Sponsors and Collaborators
Sonitus Medical Inc
Investigators
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Principal Investigator: Charles Syms, MD Ear Medical Group
More Information
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Additional Information:

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Responsible Party: Sonitus Medical Inc
ClinicalTrials.gov Identifier: NCT01933386    
Other Study ID Numbers: CLN008
First Posted: September 2, 2013    Key Record Dates
Last Update Posted: October 29, 2013
Last Verified: October 2013
Keywords provided by Sonitus Medical Inc:
Single Sided Deafness
SSD
Unilateral hearing loss
Additional relevant MeSH terms:
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Deafness
Hearing Loss
Hearing Disorders
Ear Diseases
 Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases