SoundBite Hearing System Long Term Multi Site Patient Use Study

Conductive Hearing Loss Clinical Trial

Official title:

SoundBite Hearing System Long Term Multi Site Patient Use Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01445977
• Other study ID #: CLN006
• Status: Active, not recruiting
• Phase: N/A
• First received: September 28, 2011
• Last updated: August 1, 2013
• Start date: September 2011
• Est. completion date: September 2013

Study information

• Verified date: August 2013
• Source: Sonitus Medical Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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).

Description:

The Sonitus SoundBite Hearing System prosthetic device is a bone conduction device that has been FDA cleared for treatment of single-sided deafness (SSD) and conductive hearing loss (CHL). The Sonitus SoundBite Hearing System consists of an In the Mouth (ITM) component an external microphone component, worn behind the ear (BTE), a calibration interface cable and PC-controlled calibration software for subject calibration. A charger is also provided to charge the ITM and the BTE. The objective of this multi-sites observational study is to assess the long-term patient use of the Sonitus SoundBite Hearing System.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Conductive Hearing Loss
• Deafness
• Hearing Loss
• Hearing Loss, Conductive
• Single Sided Deafness

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sonitus Medical Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aided Threshold Testing	Aided threshold testing of the impaired ear at 12 months as compared with baseline using the SoundBite Hearing System	12 months	No
Primary	Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire	Change in Abbreviated Profile of Hearing Aid Benefit (APHAB, Form A - New Format, Hearing Aid Research Lab, University of Memphis, 1994) score at 12 months compared to baseline	12 months	No
Primary	Single Sided Deafness Questionnaire	This questionnaire assesses qualitative outcomes.	12 months	No

External Links

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