Clinical trial NCT01108406: Long Term Safety of the Sonitus SoundBite System
Official title: Long Term Safety of the Sonitus SoundBite System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Unilateral Hearing Loss
Total Unilateral Deafness
Keywords: Hearing Loss
Unilateral Hearing Loss
Single Sided Deafness
Lead sponsor: Sonitus Medical Inc
Sponsor class: INDUSTRY
First posted: 2010-04-22
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

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 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

Primary outcomes:
measure: Long Term Safety
timeFrame: 6 months
Secondary outcomes:
measure: Measurement of Device Benefit With the Abbreviated Profile of Hearing Aid Benefit (APHAB)
timeFrame: 3 months and 6 months
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Camino Ear Nose and Throat
state: California
Study officials:
affiliation: Camino ENT
name: Michael Murray, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.