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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: October 10, 2014
Last verified: October 2014
  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
Device: The Sonitus Bone Conduction Hearing System
Device: SoundBite
Device: SoundBite 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:


Further study details as provided by Sonitus Medical Inc:

Primary Outcome Measures:
  • Incidence of Device- and Procedure-related Adverse Events at 30 Days [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

    The safety parameters for the trial were monitored throughout the Evaluation Phase (30 days). The safety checks included:

    Comprehensive Medical evaluation at Enrollment and at Termination Comprehensive Dental evaluation at Enrollment and at Termination, with interim dental checks at each visit in between, if needed Comprehensive Audiological evaluation at Enrollment and Termination.


  • Efficacy: Ability to Understand Speech in Noise [ Time Frame: Day 1, Day 30 ] [ Designated as safety issue: No ]
    The primary efficacy outcome was a measure of the ability to understand speech in noise while wearing the device compared with not wearing the device. The Hearing in Noise Test (HINT) was utilized for this measure as it is the most widely used test for SSD devices. An improvement in HINT score is indicated as a negative (-) dB value change. A more negative (-dB) value indicates an improvement in understanding speech in noise. An improvement in a HINT score of -1 dB is equivalent to a 10% improvement in the ability to understand speech in noise and is likely of clinical benefit. The scores are calculated as HINT Advantage (aided compared with unaided) which depict the differences of using a device as compared to not wearing a device.


Secondary Outcome Measures:
  • Measure of Benefit of SoundBite Using Abbreviated Profile of Hearing Aid Benefit (APHAB). [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    The measure of the benefit of the device was assessed using the Abbreviated Profile of Hearing Aid Benefit (APHAB), a 24-item self-assessment inventory in which the amount of difficulty in everyday situations is reported with larger numbers indicating more difficulty. Device benefit is calculated by subtracting the score obtained after using a device from the score obtained before using the device. A software program is utilized to score the APHAB and results are compared a different time points. The APHAB is well characterized and broadly used as a quantifiable measurement of device benefit. The APHAB benefit scores can range from -99 (treatment worse than no treatment) to +99 (treatment better than no treatment)


Enrollment: 35
Study Start Date: September 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SoundBite Hearing System
The objective of this study was to assess the safety and effectiveness of the SoundBite hearing system by Sonitus Medical and to support its intended use for the treatment of unilateral hearing loss. The SoundBite hearing system is a Bone Conduction Device (BCD) and is occasionally referred to as such in the protocol and within this report.
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.
Device: SoundBite Device: SoundBite Hearing System

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
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: 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

Additional Information:
Publications:

Responsible Party: Sonitus Medical Inc
ClinicalTrials.gov Identifier: NCT00977314     History of Changes
Other Study ID Numbers: CLN002
Study First Received: September 14, 2009
Results First Received: June 4, 2013
Last Updated: October 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sonitus Medical Inc:
Unilateral Hearing Loss

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

ClinicalTrials.gov processed this record on November 20, 2014