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Bone Conduction Auditory Performance Via the Tooth for Single-Sided Deafness

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sonitus Medical Inc
ClinicalTrials.gov Identifier:
NCT00977314
First received: September 14, 2009
Last updated: June 12, 2012
Last verified: June 2012
History of Changes
  Purpose

The purpose of this study is to determine the safety and efficacy of using bone conduction via the teeth to treat Single-Sided Deafness (SSD).


Condition Intervention
Unilateral Hearing Loss
Single Sided Deafness
 Device: The Sonitus Bone Conduction Hearing System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bone Conduction Auditory Performance Via the Tooth for Single-Sided Deafness

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sonitus Medical Inc:

Primary Outcome Measures:
  • Effectiveness is defined as an improvement in speech intelligibility based on "Change from Baseline" analysis of a Hearing in Noise Test (HINT), Noise on Better Side Scores (HNBS) between without the BCD and with the BCD at day thirty. [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of device- and procedure-related adverse events at 30 days [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Change in Abbreviated Profile of Hearing Aid Benefit (APHAB, Form A - New Format, Hearing Aid Research Lab, University of Memphis, 1994) to assess the subject's experience with the device [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • SSD Questionnaire score after 30 days to assess subject's experience with the device [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
  • The Remaining conditions of the HINT (Speech front in Quiet, Speech front with noise from the front and Speech front with noise from worse ear side) [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: September 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: The Sonitus Bone Conduction Hearing System
    Comparison of HINT scores (Speech front with noise at better ear) at 30 days tested with the device in place verses with the device removed.
Detailed Description:

The Sonitus Bone Conduction Device (BCD) is a bone conduction device for single-sided deafness (SSD). The Sonitus BCD consists of an Oral Appliance (OA), an external microphone component, worn behind the ear (BTE), a calibration interface cable and a PC-controlled calibration software for subject calibration. The Sonitus BCD picks up sounds from a microphone located within the ear canal of the deaf ear, capitalizing on the acoustics of the natural pinna and ear canal. The signal picked up by the microphone is then transmitted wirelessly to a removeable bone conduction oral appliance located on the upper molars. The oral appliance receives the acoustic signal from the BTE and applies an equivalent vibratory signal to the teeth that reaches the skull via bone conduction and routed transcranially to the contralateral cochlea.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be >18, < 80 years old
  • Must be fluent in English, as determined by the PI
  • Must not be a member of a vulnerable group (IRB defined)
  • Must remain in geographic area during duration of the study
  • Diagnosis of acquired SSD (Section 3.1), time since onset (≥3 mos)
  • Must have a minimum of 6 posterior teeth remaining in the upper arch (3 teeth per side),third molars are acceptable if healthy, fully erupted and substituting for second molars

Exclusion Criteria:

  • Must not be current users of devices such as Baha, CROS or TransEar

  • Must not have known active medical causes of SSD:

    • Active middle ear pathology
    • Conductive HL (Otosclerosis, otitis media, otitis externa and others)
    • Sudden hearing loss that is not stable
  • Must not have known medical problems that might be life-threatening or is a contraindication for elective dental or medical procedures
  • Must not have known problems that may interfere with the impression procedure, such as inability to breath through nose (e.g. severe flu, allergies or cold)
  • Must not have allergies to polymers

  • Must not have known dental abnormalities:

    • Temporary crowns or undergoing dental treatment
    • Poor oral hygiene and/or rampant decay
    • Current orthodontics
    • Active caries in one or more of the possible abutment teeth for the device
    • Active moderate to severe periodontal disease around abutment teeth for the device
    • Suspicious oral/facial lesions or swelling of any type
    • Severe pain on palpation on any area of mouth, face or neck
    • Moderate to severe heat sensitivity on any of the upper teeth
    • Subject currently being treated for temporomandibular joint disorder (TMJ), pain, full mouth reconstruction or posterior dental implants

  • Must not have known Audiological conditions:

    • Conductive hearing loss (air-bone gap >10dB HL at more than 3 frequencies)
    • Word recognition scores inconsistent with pure tone averages
    • Fluctuating hearing loss
  • Must not have known psychological factors that interfere with their ability to comply, comprehend, consent and cooperate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00977314

Locations
United States, California
Hearing Resource Center
Redwood City, California, United States, 94063
Camino Ear Nose and Throat
San Jose, California, United States, 95123
Sponsors and Collaborators
Sonitus Medical Inc
Investigators
Principal Investigator: Michael Murray, MD
  More Information

Publications:

Responsible Party: Sonitus Medical Inc
ClinicalTrials.gov Identifier: NCT00977314     History of Changes
Other Study ID Numbers: 08132-01C
Study First Received: September 14, 2009
Last Updated: June 12, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Sonitus Medical Inc:
Unilateral Hearing Loss
Single Sided Deafness

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

ClinicalTrials.gov processed this record on May 22, 2013