Bone Conduction Auditory Performance Via the Tooth for Single-Sided Deafness
NCT ID: NCT00977314
Last Updated: 2014-10-17
Study Results
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View full resultsBasic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2009-09-30
2010-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
SoundBite
SoundBite Hearing System
Interventions
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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.
SoundBite
SoundBite Hearing System
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
80 Years
ALL
No
Sponsors
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Sonitus Medical Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Murray, MD
Role: PRINCIPAL_INVESTIGATOR
Locations
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Hearing Resource Center
Redwood City, California, United States
Camino Ear Nose and Throat
San Jose, California, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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SoundBite Hearing Device
Sonitus Medical Corporate Page
Other Identifiers
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CLN002
Identifier Type: -
Identifier Source: org_study_id
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