Long Term Safety of the Sonitus SoundBite System
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Purpose
The objective of this study is to assess the long-term safety and quality of life improvement of the Sonitus SoundBite Hearing System.
| Condition | Intervention |
|---|---|
|
Hearing Loss Unilateral Hearing Loss Single Sided Deafness |
Device: Sonitus SoundBite System |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Long Term Safety of the Sonitus SoundBite System |
- Determination of the safety of the Sonitus SoundBite System. [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]
Subjects will be examined at each time point by a dental professional to ensure the proper dental fit and by an audiologist for device calibration if necessary. These safety checks will include:
- 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.
- Comprehensive Audiological evaluation at Enrollment and at 6 months.
- Determination of the quality of life improvement of the Sonitus SoundBite System [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]The subjects will complete an Abbreviated Profile of Hearing Aid Benefit (APHAB Form A New Format) questionnaire at day one at 3 and 6 months. This questionnaire assesses the extent of communication problems in everyday life. An SSD questionnaire will be filled out at 3 months and 6 months to measure subject satisfaction with the device.
| Enrollment: | 22 |
| Study Start Date: | April 2010 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
-
Device: Sonitus SoundBite System
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| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | Sonitus Medical Inc |
| ClinicalTrials.gov Identifier: | NCT01108406 History of Changes |
| Other Study ID Numbers: | CLN005.00 |
| Study First Received: | April 15, 2010 |
| Last Updated: | June 12, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sonitus Medical Inc:
|
Hearing Loss Unilateral Hearing Loss Single Sided Deafness |
Additional relevant MeSH terms:
|
Deafness Hearing Loss Hearing Loss, Unilateral Hearing Disorders Ear Diseases |
Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013