Long Term Safety of the Sonitus SoundBite System

Hearing Loss Clinical Trial

Official title:

Long Term Safety of the Sonitus SoundBite System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01108406
• Other study ID #: CLN005.00
• Status: Completed
• Phase: N/A
• First received: April 15, 2010
• Last updated: October 10, 2014
• Start date: April 2010
• Est. completion date: December 2010

Study information

• Verified date: October 2014
• Source: Sonitus Medical Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to assess the long-term safety and quality of life improvement of the Sonitus SoundBite Hearing System.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Unilateral
• Total Unilateral Deafness
• Unilateral Hearing Loss

Intervention

Device:
• Sonitus SoundBite System
Non Surgical Bone Conduction Device
• SoundBite Hearing System

Locations

Country	Name	City	State
United States	Camino Ear Nose and Throat	San Jose	California

Sponsors (1)

Lead Sponsor	Collaborator
Sonitus Medical Inc

Country where clinical trial is conducted

United States, 

References & Publications (10)

Dahlin GC, Allen FG, Collard EW. Bone-conduction thresholds of human teeth. J Acoust Soc Am. 1973 May;53(5):1434-7. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Stenfelt SP, Håkansson BE. Sensitivity to bone-conducted sound: excitation of the mastoid vs the teeth. Scand Audiol. 1999;28(3):190-8. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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).	3 months and 6 months	No

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