Bone Conduction Auditory Performance Via the Tooth for Single-Sided Deafness
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Unilateral Hearing Loss
- Sponsor
- Sonitus Medical Inc
- Enrollment
- 35
- Locations
- 2
- Primary Endpoint
- Incidence of Device- and Procedure-related Adverse Events at 30 Days
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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 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.
Investigators
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 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
Outcomes
Primary Outcomes
Incidence of Device- and Procedure-related Adverse Events at 30 Days
Time Frame: 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.
Efficacy: Ability to Understand Speech in Noise
Time Frame: Day 1, Day 30
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.
Secondary Outcomes
- Measure of Benefit of SoundBite Using Abbreviated Profile of Hearing Aid Benefit (APHAB).(30 days)