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
  Purpose

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


Condition Intervention
Hearing Loss
Unilateral Hearing Loss
Total Unilateral Deafness
Device: Sonitus SoundBite System
Device: SoundBite Hearing System

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long Term Safety of the Sonitus SoundBite System

Resource links provided by NLM:


Further study details as provided by Sonitus Medical Inc:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Enrollment: 22
Study Start Date: April 2010
Study Completion Date: December 2010
Primary Completion Date: December 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 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.

Device: Sonitus SoundBite System
Non Surgical Bone Conduction Device
Other Name: Sonitus Bone Conduction Device
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 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
  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: NCT01108406

Locations
United States, California
Camino Ear Nose and Throat
San Jose, California, United States, 95123
Sponsors and Collaborators
Sonitus Medical Inc
Investigators
Principal Investigator: Michael Murray, MD Camino ENT
  More Information

Additional Information:
Publications:

Responsible Party: Sonitus Medical Inc
ClinicalTrials.gov Identifier: NCT01108406     History of Changes
Other Study ID Numbers: CLN005.00
Study First Received: April 15, 2010
Results First Received: June 1, 2013
Last Updated: October 10, 2014
Health Authority: United States: Food and Drug Administration

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

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 October 23, 2014