(122 days)
The Ponto bone anchored hearing implant system is intended for the following patients and indications;
- . Patient with conductive or mixed hearing losses, who can still benefit from amplification of the sound. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear should be better than or equal to 45 dB HL for use with the Ponto and Ponto Pro sound processors, 55 dB HL for use with the Ponto Pro Power sound processor.
- . Bilateral fitting is applicable for most patients having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2 and 4 kHz, or less than 15 dB at individual frequencies.
- . Patients who have 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 (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz).
- Also indicated for any patient who is 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.
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This document is a 510(k) premarket notification decision letter from the FDA for the Oticon Medical AB Ponto Bone Anchored Hearing Implant System. The document confirms that the device is substantially equivalent to legally marketed predicate devices.
The document in the prompt does not contain information about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement in a study. It is a regulatory approval letter, not a study report. Therefore, I cannot provide the requested information based solely on the provided text.
The closest information available is the Indications for Use statement (Page 2), which outlines the patient criteria for which the device is intended. This specifies target hearing loss levels (e.g., "better than or equal to 45 dB HL" for certain processors) and conditions (conductive, mixed, or single-sided deafness). However, these are eligibility criteria for patients, not acceptance criteria for the device's performance measured in a study.
§ 874.3302 Bone-conduction hearing aid.
(a)
Identification. A bone-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing and that conducts sound to the inner ear through the skull. The non-implantable components of a bone-conduction hearing aid, such as the external sound processor, are subject to the requirements in § 801.422 of this chapter.(b)
Classification. Class II.