Trial record 16 of 471 for:    Deafness

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")

This study is not yet open for participant recruitment.
Verified October 2013 by Sonitus Medical Inc
Sponsor:
Information provided by (Responsible Party):
Sonitus Medical Inc
ClinicalTrials.gov Identifier:
NCT01933386
First received: August 28, 2013
Last updated: October 25, 2013
Last verified: October 2013
  Purpose

The primary objective of this study is to compare the SoundBite™ Hearing System to surgically implanted BCD systems.


Condition Intervention Phase
Single Sided Deafness
Device: SoundBite
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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")

Resource links provided by NLM:


Further study details as provided by Sonitus Medical Inc:

Primary Outcome Measures:
  • APHAB Questionnaire [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Comparison of the SoundBite™ System and surgically implanted bone conduction devices


Secondary Outcome Measures:
  • Single Sided Deafness Questionnaire [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Comparison of the SoundBite™ System and surgically implanted BCD systems.


Estimated Enrollment: 15
Study Start Date: September 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01933386

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

Locations
United States, Arizona
Arizona Ear Center Recruiting
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 Recruiting
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 Recruiting
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
Principal Investigator: Charles Syms, MD Ear Medical Group
  More Information

Additional Information:
No publications provided

Responsible Party: Sonitus Medical Inc
ClinicalTrials.gov Identifier: NCT01933386     History of Changes
Other Study ID Numbers: CLN008
Study First Received: August 28, 2013
Last Updated: October 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Sonitus Medical Inc:
Single Sided Deafness
SSD
Unilateral hearing loss

Additional relevant MeSH terms:
Deafness
Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014