SoundBite Hearing System 24 Month Multi Site Patient Use Study

Status unconfirmed

Conditions studied: Single Sided Deafness, Conductive Hearing Loss

In brief

The objective of this multi-site observational study is to further assess the long-term patient use of the Sonitus SoundBite Hearing System. Information can be gained by assessing benefit for the subjects that were enrolled in the SoundBite Hearing System Long Term Multi Site Study (Protocol CLN006) for an additional 12 months.

Key facts

Study ID

NCT01807559

Run by

Sonitus Medical Inc

People needed

75

Starts

2013-03-01

Expected to finish

2014-08-01

Last updated by the study team

2013-05-03

Who can join

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

You may qualify if…

• Subjects who previously were enrolled in SoundBite Hearing System Long Term Multi Site Patient Use Study (Protocol CLN006) and completed the 12 month study visit.
• Additionally, subjects must meet one of the two criteria for hearing loss:
• Moderately severe, severe, or profound sensorineural hearing loss in one ear and normal hearing in the other ear (i.e. single sided deafness or "SSD"). 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.
• OR
• 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.

You may not qualify if…

• Subjects that do not meet one of the two the audiometric criteria as measured on the audiogram for the 12 month study appointment for Protocol CLN006:
• A moderately severe, severe, or profound sensorineural hearing loss in one ear and normal hearing in the other ear (i.e. single sided deafness or -SSD‖). 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 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
• 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 use their hands such as paraplegics or others that are unable to comply with the warnings in the product's labeling.

Where it is running

• University Health Science Center (University of Utah Hospital) — Salt Lake City, Utah, United States (enrolling)
• California Hearing and Balance — La Jolla, California, United States (enrolling)
• Shohet Ear Associates — Newport Beach, California, United States (enrolling)
• Arizona Ear Center — Phoenix, Arizona, United States (enrolling)
• Physicians Choice Hearing and Balance — Tampa, Florida, United States (enrolling)
• Ear Medical Group — San Antonio, Texas, United States (enrolling)
• The George Washington University-Department of Otolaryngology — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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