Status:
COMPLETED
Bone Conduction Auditory Performance Via the Tooth for Single-Sided Deafness
Lead Sponsor:
Sonitus Medical Inc
Conditions:
Unilateral Hearing Loss
Eligibility:
All Genders
18-80 years
Phase:
NA
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).
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00977314
Start Date
September 1 2009
End Date
February 1 2010
Last Update
October 17 2014
Active Locations (2)
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1
Hearing Resource Center
Redwood City, California, United States, 94063
2
Camino Ear Nose and Throat
San Jose, California, United States, 95123