Clinical trial NCT01807559: SoundBite Hearing System 24 Month Multi Site Patient Use Study
Official title: SoundBite Hearing System 24 Month Multi Site Patient Use Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Single Sided Deafness
Conductive Hearing Loss
Keywords: Single Sided Deafness
Conductive Hearing Loss
Unilateral Hearing Loss
SSD
Lead sponsor: Sonitus Medical Inc
Sponsor class: INDUSTRY
First posted: 2013-03-08
Enrollment: 75
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 who are already currently using SoundBite Hearing System for treatment of their SSD or CHL and were enrolled in the SoundBite Hearing System Long Term Multi Site Patient Use Study (Protocol CLN0006). Participants are willing to participate in this study.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire
timeFrame: 24 Months
Secondary outcomes:
measure: Aided Threshold Testing
timeFrame: 24 Months
Other outcomes:
measure: Single Sided Deafness Questionnaire
timeFrame: 24 Months
Locations:
city: Phoenix
country: United States
facility: Arizona Ear Center
state: Arizona
city: La Jolla
country: United States
facility: California Hearing and Balance
state: California
city: Newport Beach
country: United States
facility: Shohet Ear Associates
state: California
city: Washington
country: United States
facility: The George Washington University-Department of Otolaryngology
state: District of Columbia
city: Tampa
country: United States
facility: Physicians Choice Hearing and Balance
state: Florida
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:
References: