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

NCT00977314 | Completed Results DMC

• 1 other identifier: CLN002
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

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).

Conditions

Unilateral Hearing Loss

Keywords

Unilateral Hearing Loss

Outcome Measures

Primary Outcomes (2)

• 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.

  30 days

• 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.

  Day 1, Day 30

Secondary Outcomes (1)

• Measure of Benefit of SoundBite Using Abbreviated Profile of Hearing Aid Benefit (APHAB).

  30 days

Study Arms (1)

SoundBite Hearing System

EXPERIMENTAL

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.

Device: The Sonitus Bone Conduction Hearing System; Device: SoundBite; Device: SoundBite Hearing System

Interventions

The Sonitus Bone Conduction Hearing System DEVICE

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 Hearing System

SoundBite DEVICE

SoundBite Hearing System

SoundBite Hearing System DEVICE

SoundBite Hearing System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sonitus Medical Inc: lead

Study Sites (2)

Hearing Resource Center

Redwood City, California, 94063, United States

Location

Camino Ear Nose and Throat

San Jose, California, 95123, United States

Location

Related Publications (10)

• 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.

  PMID: 16411423 BACKGROUND

• 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.

  PMID: 18569108 BACKGROUND

• 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.

  PMID: 4712563 BACKGROUND

• 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.

  PMID: 11404603 BACKGROUND

• 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.

  PMID: 12958575 BACKGROUND

• 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.

  PMID: 10489868 BACKGROUND

• 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.

  PMID: 21799455 BACKGROUND

• 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.

  PMID: 22403981 BACKGROUND

• 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.

  PMID: 19816229 BACKGROUND

• 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.

  PMID: 21221045 RESULT

Related Links

• SoundBite Hearing Device
• Sonitus Medical Corporate Page

MeSH Terms

Conditions

Hearing Loss, Unilateral

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Trials Manager
• Organization: Sonitus Medical, Inc.

lily@sonitusmedical.com

8668162076

Study Officials

• Michael Murray, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2009
• First Posted: September 15, 2009
• Study Start: September 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: October 17, 2014
• Results First Posted: October 17, 2014

Record last verified: 2014-10

Locations

US (2)