Evaluation of Benefit for Treatment of Single Sided Deafness (SSD) Between Two Bone Conduction Prosthetic Devices; Osseointegrated Implant Versus Maxilla Anchored Removable Oral Appliance ("SoundBite")

Status unconfirmed · Phase 4

Conditions studied: Single Sided Deafness

In brief

The primary objective of this study is to compare the SoundBite™ Hearing System to surgically implanted BCD systems.

Key facts

Study ID

NCT01933386

Run by

Sonitus Medical Inc

People needed

15

Starts

2013-09-01

Expected to finish

2014-02-01

Last updated by the study team

2013-10-29

Who can join

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

You may qualify if…

• Must be current users of a surgically implanted digitally programmable surgically implanted bone conduction device
• Must be >18, <80 years old
• Must be fluent in English, as determined by the PI
• Must have diagnosis of SSD, time since onset (≥3 months)
• Must have at least two contiguous molar or premolar teeth with no untreated tooth decay. Patients with tooth decay present are to first have restorations before being fitted for SoundBite
• Healthy attachment to those teeth with tooth pockets limited to no more than 5mm

You may not qualify if…

• Subjects with known hypersensitivity to any of the components including allergies to polymers.
• Subjects that are unable to use their hands such as quadriplegics or others that are unable to comply with the warnings in the product's labeling.
• Subjects with known or active secondary medical conditions associated with variable sensorineural hearing loss

Where it is running

• Arizona Ear Center — Phoenix, Arizona, United States
• Michigan Ear Institute — Novi, Michigan, United States
• Ear Medical Group — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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