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

Primary Purpose

Unilateral Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The Sonitus Bone Conduction Hearing System
SoundBite
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 Unilateral Hearing Loss focused on measuring Unilateral Hearing Loss

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 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

  • Hearing Resource Center
  • 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 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.

Outcomes

Primary Outcome Measures

Incidence of Device- and Procedure-related Adverse Events at 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
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).
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)

Full Information

First Posted
September 14, 2009
Last Updated
October 10, 2014
Sponsor
Sonitus Medical Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00977314
Brief Title
Bone Conduction Auditory Performance Via the Tooth for Single-Sided Deafness
Official Title
Bone Conduction Auditory Performance Via the Tooth for Single-Sided Deafness
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 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 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (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 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.
Intervention Type
Device
Intervention Name(s)
The Sonitus Bone Conduction Hearing System
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
SoundBite
Intervention Type
Device
Intervention Name(s)
SoundBite Hearing System
Primary Outcome Measure Information:
Title
Incidence of Device- and Procedure-related Adverse Events at 30 Days
Description
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.
Time Frame
30 days
Title
Efficacy: Ability to Understand Speech in Noise
Description
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.
Time Frame
Day 1, Day 30
Secondary Outcome Measure Information:
Title
Measure of Benefit of SoundBite Using 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. 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)
Time Frame
30 days

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 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
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hearing Resource Center
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
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
18569108
Citation
Soli SD, Wong LL. Assessment of speech intelligibility in noise with the Hearing in Noise Test. Int J Audiol. 2008 Jun;47(6):356-61. doi: 10.1080/14992020801895136. No abstract available.
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
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
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
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
result
Links:
URL
http://www.soundbitehearing.com
Description
SoundBite Hearing Device
URL
http://sonitusmedical.com
Description
Sonitus Medical Corporate Page

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

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