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Long Term Safety of the Sonitus SoundBite System

Primary Purpose

Hearing Loss, Unilateral Hearing Loss, Total Unilateral Deafness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sonitus SoundBite System
SoundBite Hearing System
Sponsored by
Sonitus Medical Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss focused on measuring Hearing Loss, Unilateral Hearing Loss, Single Sided Deafness

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Camino Ear Nose and Throat

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SoundBite Hearing System

Arm Description

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.

Outcomes

Primary Outcome Measures

Long Term Safety
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)
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).

Full Information

First Posted
April 15, 2010
Last Updated
October 10, 2014
Sponsor
Sonitus Medical Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01108406
Brief Title
Long Term Safety of the Sonitus SoundBite System
Official Title
Long Term Safety of the Sonitus SoundBite System
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sonitus Medical Inc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of this study is to assess the long-term safety and quality of life improvement of the Sonitus 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Unilateral Hearing Loss, Total Unilateral Deafness
Keywords
Hearing Loss, Unilateral Hearing Loss, Single Sided Deafness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SoundBite Hearing System
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Sonitus SoundBite System
Other Intervention Name(s)
Sonitus Bone Conduction Device
Intervention Description
Non Surgical Bone Conduction Device
Intervention Type
Device
Intervention Name(s)
SoundBite Hearing System
Primary Outcome Measure Information:
Title
Long Term Safety
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Measurement of Device Benefit With the Abbreviated Profile of Hearing Aid Benefit (APHAB)
Description
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).
Time Frame
3 months and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Murray, MD
Organizational Affiliation
Camino ENT
Official's Role
Principal Investigator
Facility Information:
Facility Name
Camino Ear Nose and Throat
City
San Jose
State/Province
California
ZIP/Postal Code
95123
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16411423
Citation
Ozer E, Adelman C, Freeman S, Sohmer H. Bone conduction hearing on the teeth of the lower jaw. J Basic Clin Physiol Pharmacol. 2002;13(2):89-96. doi: 10.1515/jbcpp.2002.13.2.89.
Results Reference
background
PubMed Identifier
4712563
Citation
Dahlin GC, Allen FG, Collard EW. Bone-conduction thresholds of human teeth. J Acoust Soc Am. 1973 May;53(5):1434-7. doi: 10.1121/1.1913490. No abstract available.
Results Reference
background
PubMed Identifier
11404603
Citation
Wazen JJ, Spitzer J, Ghossaini SN, Kacker A, Zschommler A. Results of the bone-anchored hearing aid in unilateral hearing loss. Laryngoscope. 2001 Jun;111(6):955-8. doi: 10.1097/00005537-200106000-00005.
Results Reference
background
PubMed Identifier
12958575
Citation
Wazen JJ, Spitzer JB, Ghossaini SN, Fayad JN, Niparko JK, Cox K, Brackmann DE, Soli SD. Transcranial contralateral cochlear stimulation in unilateral deafness. Otolaryngol Head Neck Surg. 2003 Sep;129(3):248-54. doi: 10.1016/S0194-5998(03)00527-8.
Results Reference
background
PubMed Identifier
10489868
Citation
Stenfelt SP, Hakansson BE. Sensitivity to bone-conducted sound: excitation of the mastoid vs the teeth. Scand Audiol. 1999;28(3):190-8. doi: 10.1080/010503999424761.
Results Reference
background
PubMed Identifier
23859058
Citation
Moore BC, Popelka GR. Preliminary comparison of bone-anchored hearing instruments and a dental device as treatments for unilateral hearing loss. Int J Audiol. 2013 Oct;52(10):678-86. doi: 10.3109/14992027.2013.809483. Epub 2013 Jul 17.
Results Reference
background
PubMed Identifier
21221045
Citation
Murray M, Popelka GR, Miller R. Efficacy and safety of an in-the-mouth bone conduction device for single-sided deafness. Otol Neurotol. 2011 Apr;32(3):437-43. doi: 10.1097/MAO.0b013e3182096b1d.
Results Reference
background
PubMed Identifier
22403981
Citation
Miller R, Hujoel P, Murray M, Popelka GR. Safety of an intra-oral hearing device utilizing a split-mouth research design. J Clin Dent. 2011;22(5):159-62.
Results Reference
background
PubMed Identifier
19816229
Citation
Popelka GR, Derebery J, Blevins NH, Murray M, Moore BC, Sweetow RW, Wu B, Katsis M. Preliminary evaluation of a novel bone-conduction device for single-sided deafness. Otol Neurotol. 2010 Apr;31(3):492-7. doi: 10.1097/MAO.0b013e3181be6741.
Results Reference
background
PubMed Identifier
21799455
Citation
Murray M, Miller R, Hujoel P, Popelka GR. Long-term safety and benefit of a new intraoral device for single-sided deafness. Otol Neurotol. 2011 Oct;32(8):1262-9. doi: 10.1097/MAO.0b013e31822a1cac.
Results Reference
result
Links:
URL
http://www.sonitusmedical.com
Description
Company Website
URL
http://www.soundbitehearing.com
Description
product website

Learn more about this trial

Long Term Safety of the Sonitus SoundBite System

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