Long Term Safety of the Sonitus SoundBite System

Not Applicable

Completed

Conditions: Hearing Loss
Total Unilateral Deafness
Unilateral Hearing Loss

Interventions: Device: Sonitus SoundBite System
Device: SoundBite Hearing System

Registration Number: NCT01108406

Lead Sponsor: Sonitus Medical Inc

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 22

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SoundBite Hearing System	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.
SoundBite Hearing System	Sonitus SoundBite 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.

Primary Outcome Measures

Name	Time	Method
Long Term Safety	6 months	The safety outcomes were defined as no changes in medical, auditory, or dental status and no device or procedure related adverse events during the study period. Safety was evaluated by conducting a 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 and Comprehensive Audiological evaluation at Enrollment and at 6 months.

Secondary Outcome Measures

Name	Time	Method
Measurement of Device Benefit With the Abbreviated Profile of Hearing Aid Benefit (APHAB)	3 months and 6 months	The measure of the benefit of the device was assessed using the Abbreviated Profile of Hearing Aid Benefit (APHAB) , a 24-item self-assessment inventory in which the amount of difficulty in everyday situations is reported with larger numbers indicating more difficulty. Device benefit is calculated by subtracting the score obtained after using a device from the score obtained before using the device. Software is used to score the APHAB and results are compared from the different timepoints. The APHAB is well characterized and broadly used as a quantifiable measurement. The APHAB benefit scores can range from -99 (treatment worse than no treatment) to +99 (treatment better than no treatment).