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Long Term Safety of the Sonitus SoundBite System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sonitus Medical Inc
ClinicalTrials.gov Identifier:
NCT01108406
First received: April 15, 2010
Last updated: October 10, 2014
Last verified: October 2014

April 15, 2010
October 10, 2014
April 2010
December 2010   (final data collection date for primary outcome measure)
Long Term Safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
The safety outcomes were defined as no changes in medical, auditory, or dental status and no device or procedure related adverse events during the study period. Safety was evaluated by conducting a Comprehensive Medical evaluation at Enrollment and at study termination; Comprehensive Dental evaluation at Enrollment and at 3 and 6 months, with interim dental checks in between if necessary and Comprehensive Audiological evaluation at Enrollment and at 6 months.
Not Provided
Complete list of historical versions of study NCT01108406 on ClinicalTrials.gov Archive Site
Measurement of Device Benefit With the Abbreviated Profile of Hearing Aid Benefit (APHAB) [ Time Frame: 3 months and 6 months ] [ 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. Software is used to score the APHAB and results are compared from the different timepoints. The APHAB is well characterized and broadly used as a quantifiable measurement. The APHAB benefit scores can range from -99 (treatment worse than no treatment) to +99 (treatment better than no treatment).
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Long Term Safety of the Sonitus SoundBite System
Long Term Safety of the Sonitus SoundBite System

The objective of this study is to assess the long-term safety and quality of life improvement of the Sonitus SoundBite Hearing System.

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.

Interventional
Not Provided
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hearing Loss
  • Unilateral Hearing Loss
  • Total Unilateral Deafness
  • Device: Sonitus SoundBite System
    Non Surgical Bone Conduction Device
    Other Name: Sonitus Bone Conduction Device
  • Device: SoundBite Hearing System
Experimental: SoundBite Hearing System

The objective of this study was to assess the long-term safety and quality of life impact of the SoundBite™ Hearing System.

Safety was measured in terms of dental, audiological and medical adverse events related to device or procedure.

Quality of Life was measured in terms of changes in Abbreviated Profile of Hearing Aid Benefit (APHAB) and as reported in a quality of life survey (SSD Questionnaire).

The duration of the study was 6 months with measures taken at Day 1, 3 months and 6 months.

Interventions:
  • Device: Sonitus SoundBite System
  • Device: SoundBite Hearing System

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
December 2010
December 2010   (final data collection date for primary outcome measure)

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 a history of seizures
  • 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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01108406
CLN005.00
Yes
Sonitus Medical Inc
Sonitus Medical Inc
Not Provided
Principal Investigator: Michael Murray, MD Camino ENT
Sonitus Medical Inc
October 2014

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