SoundBite Hearing System 24 Month Multi Site Patient Use Study
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ClinicalTrials.gov Identifier: NCT01807559 |
Recruitment Status
: Unknown
Verified May 2013 by Sonitus Medical Inc.
Recruitment status was: Recruiting
First Posted
: March 8, 2013
Last Update Posted
: May 3, 2013
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Condition or disease | Intervention/treatment |
---|---|
Single Sided Deafness Conductive Hearing Loss | Device: SoundBite Hearing System |
Study Type : | Observational |
Estimated Enrollment : | 75 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | SoundBite Hearing System 24 Month Multi Site Patient Use Study |
Study Start Date : | March 2013 |
Estimated Primary Completion Date : | August 2014 |
Estimated Study Completion Date : | August 2014 |

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Device: SoundBite Hearing System
- Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire [ Time Frame: 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.
- Aided Threshold Testing [ Time Frame: 24 Months ]Aided Threshold testing of the impaired ear at 24 months as compared with baseline using the SoundBite Hearing System
- Single Sided Deafness Questionnaire [ Time Frame: 24 Months ]This questionnaire assesses quality of life outcomes.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.
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Additionally, subjects must meet one of the two criteria for hearing loss:
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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.
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Exclusion Criteria:
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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.
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01807559
Contact: Linda Galow, MS | 832-434-9730 | linda@sonitusmedical.com |
United States, Arizona | |
Arizona Ear Center | Recruiting |
Phoenix, Arizona, United States, 85004 | |
Contact: Kelly Hernanadez, AuD 602-307-9919 audiology@arizonaear.com | |
Principal Investigator: Mark Syms, MD | |
United States, California | |
California Hearing and Balance | Recruiting |
La Jolla, California, United States, 92037 | |
Contact: Sara Mattson, AuD 858-909-0770 | |
Principal Investigator: Ritvik Mehta, MD | |
Shohet Ear Associates | Recruiting |
Newport Beach, California, United States, 92663 | |
Contact: Cheryl Tanita, AuD 949-631-4327 ctanita@eardoctor.org | |
Principal Investigator: Jack Shohet, MD | |
United States, District of Columbia | |
The George Washington University-Department of Otolaryngology | Not yet recruiting |
Washington, District of Columbia, United States, 20006 | |
Contact: Rachel Lazaro, AuD 202-741-3275 rlazaro@mfa.gwu.edu | |
Principal Investigator: Ashkan Monfared, MD | |
United States, Florida | |
Physicians Choice Hearing and Balance | Recruiting |
Tampa, Florida, United States, 33613 | |
Contact: Jeffrey Clark, AuD 813-558-1477 | |
Principal Investigator: Jeffrey Clark, AuD | |
United States, Texas | |
Ear Medical Group | Recruiting |
San Antonio, Texas, United States, 78240 | |
Contact: Robyn Shanley, PhD 210-614-6070 RobynS@earmedicalgroup.com | |
Principal Investigator: Charles Syms, MD | |
United States, Utah | |
University Health Science Center (University of Utah Hospital) | Recruiting |
Salt Lake City, Utah, United States, 84132 | |
Contact: Diane Tyler, RN 801-587-4824 diane.tyler@hsc.utah.edu | |
Principal Investigator: Richard Gurgel, MD |
Additional Information:
Responsible Party: | Sonitus Medical Inc |
ClinicalTrials.gov Identifier: | NCT01807559 History of Changes |
Other Study ID Numbers: |
CLN009 |
First Posted: | March 8, 2013 Key Record Dates |
Last Update Posted: | May 3, 2013 |
Last Verified: | May 2013 |
Keywords provided by Sonitus Medical Inc:
Single Sided Deafness Conductive Hearing Loss Unilateral Hearing Loss SSD |
Additional relevant MeSH terms:
Hearing Loss Deafness Hearing Loss, Conductive Hearing Disorders Ear Diseases |
Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases Signs and Symptoms |