• Subjects must meet the following criteria to be eligible for participation in the investigation:

‣ Signed Informed Consent Form (signed by parent or legal guardian and child).

⁃ Subjects aged 12 to 17 years of age (inclusive)

⁃ Subjects with the following audiometric criteria consistent with the current and approved labeling of the device:

∙ 1 Conductive or mixed hearing loss with a pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2, and 3 kHz) of the indicated ear better than or equal to 45 dB HL.

∙ 2 OR subjects with a profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e., single-sided deafness or SSD). The pure tone average air conduction hearing (AC) thresholds of the hearing ear should be better than or equal to 20 dB HL (measured at 0.5, 1, 2, and 3 kHz).

∙ 3 OR subjects who are indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.

⁃ Prior experience with amplified sound through properly fitted amplification devices such as a hearing aid, a CROS device, or a non-surgical bone conduction solution (e.g., a softband or sound arc).

⁃ For patients with conductive or mixed hearing losses sufficient (e.g., \>25 dB) air bone gap (ABG) at the ear to be implanted.

⁃ Subjects and parent(s) or legal guardian have the ability and willingness to comply with all investigational procedures/requirements, as determined by the Investigator.