Long Term Safety of the Sonitus SoundBite System

Completed · Not applicable

Conditions studied: Hearing Loss, Unilateral Hearing Loss, Total Unilateral Deafness

In brief

The objective of this study is to assess the long-term safety and quality of life improvement of the Sonitus SoundBite Hearing System.

Key facts

Study ID

NCT01108406

Run by

Sonitus Medical Inc

People needed

22

Starts

2010-04-01

Expected to finish

2010-12-01

Last updated by the study team

2014-10-20

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Camino Ear Nose and Throat — San Jose, California, United States

Full record on ClinicalTrials.gov

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