Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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")

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2013 by Sonitus Medical Inc.
Recruitment status was:  Not yet recruiting
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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01933386

Locations
United States, Arizona
Arizona Ear Center
Phoenix, Arizona, United States, 85004
United States, Michigan
Michigan Ear Institute
Novi, Michigan, United States, 48374
United States, Texas
Ear Medical Group
San Antonio, Texas, United States, 78240
Sponsors and Collaborators
Sonitus Medical Inc
Investigators
Principal Investigator: Charles Syms, MD Ear Medical Group
  More Information

Additional Information:
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 December 02, 2016