Clinical trial NCT01445977: SoundBite Hearing System Long Term Multi Site Patient Use Study
Official title: SoundBite Hearing System Long Term Multi Site Patient Use Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Single Sided Deafness
Conductive Hearing Loss
Keywords: Sonitus Medical
SoundBite
Single Sided Deafness
Conductive Hearing Loss
Unilateral Hearing Loss
Lead sponsor: Sonitus Medical Inc
Sponsor class: INDUSTRY
First posted: 2011-10-04
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All trial subjects are individuals that have decided to purchase SoundBite Hearing System for treatment of their Single Sided Deafness or Conductive Hearing Loss and are willing to participate in this study.

Brief 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Aided Threshold Testing
timeFrame: 12 months
measure: Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire
timeFrame: 12 months
measure: Single Sided Deafness Questionnaire
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Ear Center
state: Arizona
city: LaJolla
country: United States
facility: California Hearing and Balance Center
state: California
city: Newport Beach
country: United States
facility: Shohet Ear Associates Medical Group
state: California
city: San Jose
country: United States
facility: Camino Ear, Nose and Throat Clinic
state: California
city: San Mateo
country: United States
facility: Hearing Resource Center
state: California
city: Washington
country: United States
facility: The George Washington University- Department of Otolaryngology
state: District of Columbia
city: Miami
country: United States
facility: University of Miami, Miller School of Medicine
state: Florida
city: Tampa
country: United States
facility: Physicians Choice Hearing and Dizziness Center
state: Florida
city: Detroit
country: United States
facility: Henry Ford Health System- Department of Otolayrngology and Audiology
state: Michigan
city: New York
country: United States
facility: New York Otology
state: New York
city: Raleigh
country: United States
facility: Carolina Ear and Hearing Clinic, PC
state: North Carolina
city: San Antonio
country: United States
facility: Ear Medical Group
state: Texas
city: Salt Lake City
country: United States
facility: University Health Science Center (University of Utah Hospital)
state: Utah
Study officials:
affiliation: Stanford University
name: Gerald Popelka, PhD
role: PRINCIPAL_INVESTIGATOR
References: