SoundBite Hearing System 24 Month Multi Site Patient Use Study

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.