Back to resultsEvaluation of Benefit for Treatment of Single Sided Deafness (SSD) Between Two Bone Conduction Prosthetic Devices; Osseointegrated Implant Versus Maxilla Anchored Removable Oral Appliance ("SoundBite")
Primary Purpose
Single Sided Deafness
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
SoundBite
Sponsored by
About this trial
This is an interventional treatment trial for Single Sided Deafness focused on measuring Single Sided Deafness, SSD, Unilateral hearing loss
Eligibility 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
Sites / Locations
- Arizona Ear Center
- Michigan Ear Institute
- Ear Medical Group
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
SoundBite
Surgically Implanted BCD
Arm Description
SoundBite will be used for the first 30 days
The subject's own surgically implanted bone conduction device will be used for the first 30 days.
Outcomes
Primary Outcome Measures
APHAB Questionnaire
Comparison of the SoundBite™ System and surgically implanted bone conduction devices
Secondary Outcome Measures
Single Sided Deafness Questionnaire
Comparison of the SoundBite™ System and surgically implanted BCD systems.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01933386
Brief 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")
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 Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
February 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sonitus Medical Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of this study is to compare the SoundBite™ Hearing System to surgically implanted BCD systems.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Single Sided Deafness
Keywords
Single Sided Deafness, SSD, Unilateral hearing loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SoundBite
Arm Type
Other
Arm Description
SoundBite will be used for the first 30 days
Arm Title
Surgically Implanted BCD
Arm Type
Other
Arm Description
The subject's own surgically implanted bone conduction device will be used for the first 30 days.
Intervention Type
Device
Intervention Name(s)
SoundBite
Other Intervention Name(s)
The SoundBite Hearing System
Intervention Description
Non-surgical removable bone conduction device via the teeth.
Primary Outcome Measure Information:
Title
APHAB Questionnaire
Description
Comparison of the SoundBite™ System and surgically implanted bone conduction devices
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Single Sided Deafness Questionnaire
Description
Comparison of the SoundBite™ System and surgically implanted BCD systems.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Linda Galow, M.S.
Phone
1-650-581-5094
Email
linda@sonitusmedical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Syms, MD
Organizational Affiliation
Ear Medical Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Ear Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Hernanadez, AuD
Phone
602-307-9919
Email
audiology@arizonaear.com
First Name & Middle Initial & Last Name & Degree
Mark Syms, MD
Facility Name
Michigan Ear Institute
City
Novi
State/Province
Michigan
ZIP/Postal Code
48374
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Monitz
Phone
248-465-4828
Email
Jennifer.Monitz@providence-stjohnhealth.org
First Name & Middle Initial & Last Name & Degree
Robert Hong, M.D., Ph.D.
Facility Name
Ear Medical Group
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robyn Shanley, AuD, PhD
Phone
210-614-6070
Email
RobynS@earmedicalgroup.com
First Name & Middle Initial & Last Name & Degree
Charles Syms, MD
12. IPD Sharing Statement
Links:
URL
http://soundbitehearing.com
Description
SoundBite Hearing System
Learn more about this trial
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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