Long Term Safety of the Sonitus SoundBite System

NCT01108406 | Completed Results DMC

• 1 other identifier: CLN005.00
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss; Unilateral Hearing Loss; Total Unilateral Deafness

Keywords

Hearing Loss; Unilateral Hearing Loss; Single Sided Deafness

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (1)

• Measurement of Device Benefit With the Abbreviated Profile of Hearing Aid Benefit (APHAB)

  3 months and 6 months

Study Arms (1)

SoundBite Hearing System

EXPERIMENTAL

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; Device: SoundBite Hearing System

Interventions

Sonitus SoundBite System DEVICE

Non Surgical Bone Conduction Device

Also known as: Sonitus Bone Conduction 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 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

Sponsors & Collaborators

• Sonitus Medical Inc: lead

Study Sites (1)

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

• 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

• 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.

  PMID: 23859058 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 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, 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 RESULT

Related Links

• Company Website
• product website

MeSH Terms

Conditions

Hearing Loss; Hearing Loss, Unilateral

Condition Hierarchy (Ancestors)

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: Lily Woodby, AuD
• Organization: Sonitus Medical, Inc.

lily@sonitusmedical.com

8668162076

Study Officials

• Michael Murray, MD

  Camino ENT

  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: April 15, 2010
• First Posted: April 22, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: October 20, 2014
• Results First Posted: October 10, 2014

Record last verified: 2014-10

Locations

US (1)