SoundBite Hearing System 24 Month Multi Site Patient Use Study

SoundBite Hearing System 24 Month Multi Site Patient Use Study

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.

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.