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")
1 other identifier
interventional
15
1 country
3
Brief Summary
The primary objective of this study is to compare the SoundBite™ Hearing System to surgically implanted BCD systems.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Sep 2013
Shorter than P25 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2013
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedFirst Posted
Study publicly available on registry
September 2, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedOctober 29, 2013
October 1, 2013
5 months
August 28, 2013
October 25, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
APHAB Questionnaire
Comparison of the SoundBite™ System and surgically implanted bone conduction devices
30 days
Secondary Outcomes (1)
Single Sided Deafness Questionnaire
30 days
Study Arms (2)
SoundBite
OTHERSoundBite will be used for the first 30 days
Surgically Implanted BCD
OTHERThe subject's own surgically implanted bone conduction device will be used for the first 30 days.
Interventions
Non-surgical removable bone conduction device via the teeth.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Arizona Ear Center
Phoenix, Arizona, 85004, United States
Michigan Ear Institute
Novi, Michigan, 48374, United States
Ear Medical Group
San Antonio, Texas, 78240, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charles Syms, MD
Ear Medical Group
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2013
First Posted
September 2, 2013
Study Start
September 1, 2013
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
October 29, 2013
Record last verified: 2013-10