Long Term Safety of the Sonitus SoundBite System
Hearing Loss, Unilateral Hearing Loss, Total Unilateral Deafness
About this trial
This is an interventional treatment trial for Hearing Loss focused on measuring Hearing Loss, Unilateral Hearing Loss, Single Sided Deafness
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
Sites / Locations
- Camino Ear Nose and Throat
Arms of the Study
Arm 1
Experimental
SoundBite Hearing System
The objective of this study was to assess the long-term safety and quality of life impact of the SoundBite™ Hearing System. Safety was measured in terms of dental, audiological and medical adverse events related to device or procedure. Quality of Life was measured in terms of changes in Abbreviated Profile of Hearing Aid Benefit (APHAB) and as reported in a quality of life survey (SSD Questionnaire). The duration of the study was 6 months with measures taken at Day 1, 3 months and 6 months.