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

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ClinicalTrials.gov Identifier: NCT00977314
Recruitment Status : Completed
First Posted : September 15, 2009
Results First Posted : October 17, 2014
Last Update Posted : October 17, 2014
Sponsor:
Information provided by (Responsible Party):
Sonitus Medical Inc

Tracking Information
First Submitted Date  ICMJE September 14, 2009
First Posted Date  ICMJE September 15, 2009
Results First Submitted Date  ICMJE June 4, 2013
Results First Posted Date  ICMJE October 17, 2014
Last Update Posted Date October 17, 2014
Study Start Date  ICMJE September 2009
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2014)
  • Incidence of Device- and Procedure-related Adverse Events at 30 Days [ Time Frame: 30 days ]
    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 ]
    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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00977314 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2014)
Measure of Benefit of SoundBite Using Abbreviated Profile of Hearing Aid Benefit (APHAB). [ Time Frame: 30 days ]
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)
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bone Conduction Auditory Performance Via the Tooth for Single-Sided Deafness
Official Title  ICMJE Bone Conduction Auditory Performance Via the Tooth for Single-Sided Deafness
Brief Summary 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).
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Unilateral Hearing Loss
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Device: The Sonitus Bone Conduction Hearing System
  • Device: SoundBite
  • Device: SoundBite Hearing System
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 10, 2014)
35
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00977314
Other Study ID Numbers  ICMJE CLN002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sonitus Medical Inc
Study Sponsor  ICMJE Sonitus Medical Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Murray, MD
PRS Account Sonitus Medical Inc
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP