SoundBite Hearing System 24 Month Multi Site Patient Use Study

• Conditions: Single Sided Deafness; Conductive Hearing Loss

• Registration Number: NCT01807559
• Lead Sponsor: Sonitus Medical Inc

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-06
• Study First Submitted QC: 2013-03-06
• Study First Posted: 2013-03-08
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-02
• Last Update Posted: 2013-05-03
• Primary Completion: 2014-08
• Study Completion: 2014-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• 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:

  1. 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

  2. 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.

Exclusion Criteria

• 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:

  1. 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.

  2. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire	24 Months	Change in Abbreviated Profile of Hearing Aid Benefit (APHAB, Form A- New Formate, Hearing Aid Research Lab, University of Memphis, 1994) score at 24 months compared to baseline.

Secondary Outcome Measures

Name	Time	Method
Aided Threshold Testing	24 Months	Aided Threshold testing of the impaired ear at 24 months as compared with baseline using the SoundBite Hearing System

Trial Locations

Locations (7)

Shohet Ear Associates; 🇺🇸 Newport Beach, California, United States

Physicians Choice Hearing and Balance; 🇺🇸 Tampa, Florida, United States

Ear Medical Group; 🇺🇸 San Antonio, Texas, United States

California Hearing and Balance; 🇺🇸 La Jolla, California, United States

University Health Science Center (University of Utah Hospital); 🇺🇸 Salt Lake City, Utah, United States

Arizona Ear Center; 🇺🇸 Phoenix, Arizona, United States

The George Washington University-Department of Otolaryngology; 🇺🇸 Washington, District of Columbia, United States