SoundBite Hearing System Long Term Multi Site Patient Use Study

Status unconfirmed

Conditions studied: Single Sided Deafness, Conductive Hearing Loss

In brief

This study is designed to collect data about the SoundBite™ Hearing System to answer specific questions. The hearing system has been cleared for commercial distribution by the Food and Drug Administration (FDA). Sonitus hopes to learn from a larger group of users what features and settings of this device provide the best hearing ability for people diagnosed with Single Sided Deafness (SSD) or Conductive Hearing Loss (CHL).

Key facts

Study ID

NCT01445977

Run by

Sonitus Medical Inc

People needed

150

Starts

2011-09-01

Expected to finish

2013-09-01

Last updated by the study team

2013-08-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who are 18 years or older
• Clinical diagnosis of a Moderately severe, severe, or profound sensorineural hearing loss in one ear and normal hearing in the other ear (Normal hearing is defined as a pure tone average (PTA) air-conduction (AC) hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 25 dB HL)
• Patients diagnosed with conductive hearing loss where the pure tone average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) is better than or equal to 25 dB HL.
• 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
• No mobile teeth
• Bone loss no greater than a 34% average on the mesial and distal sides of the tooth as measured on X-ray on the teeth on which the device will be worn.

You may not qualify if…

• The SoundBite Hearing System and all portions of it are contraindicated for use in an MRI Environment and should be removed prior to MRI exposure
• The SoundBite Hearing System is not to be used in patients with known hypersensitivity to any of the components including allergies to polymers.
• The SoundBite Hearing system is contraindicated for vulnerable populations that are unable to sue their hands such as paraplegics or others that are unable to comply with the warnings in the product's labeling.

Where it is running

• Hearing Resource Center — San Mateo, California, United States
• The George Washington University- Department of Otolaryngology — Washington D.C., District of Columbia, United States
• University of Miami, Miller School of Medicine — Miami, Florida, United States
• Physicians Choice Hearing and Dizziness Center — Tampa, Florida, United States
• Henry Ford Health System- Department of Otolayrngology and Audiology — Detroit, Michigan, United States
• New York Otology — New York, New York, United States
• Carolina Ear and Hearing Clinic, PC — Raleigh, North Carolina, United States
• Ear Medical Group — San Antonio, Texas, United States
• University Health Science Center (University of Utah Hospital) — Salt Lake City, Utah, United States
• Arizona Ear Center — Phoenix, Arizona, United States
• California Hearing and Balance Center — La Jolla, California, United States
• Shohet Ear Associates Medical Group — Newport Beach, California, United States
• Camino Ear, Nose and Throat Clinic — San Jose, California, United States

Full record on ClinicalTrials.gov

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