(189 days)
The Ponto Pro Power 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 of the indicated ear should be better than or equal to 55 dB HL (measured at 0.5, 1, 2 and 3 kHz)
- 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.
The placement of a bone anchored implant is contraindicated for patient below the age of 5.
The Ponto Pro Power sound processor is intended to be connected to the Oticon Medical bone anchored implant system or to the Baha@ Abutment snap coupling from Cochlear Bone Anchored Solutions AB (ref no. 90410, 90305, 90434, 90480).
Ponto Pro Power is a bone conduction hearing aid which is connected to an implant with a skin penetrating abutment which has been surgically anchored in the bone behind the ear. Vibrations generated by the sound processor are transmitted directly through the skull bone to the cochlea as bone conduction sound. Ponto Pro Power has a coupling so that it can easily be connected and disconnected from the abutment by the user or alternatively from a head band accessory, to function as a conventional bone conductor. Using a computer based fitting system, Genie Medical; Ponto Pro Power can be adjusted to the patient's individual hearing requirements. Ponto Pro Power contains a number of advanced features: Wind Noise Reduction, Feedback Management System (Feedback Manager and Dynamic Feedback Cancellation), Automatic Gain Control, Speech Guard, BC In-situ Audiometry, Automatic Multiband Adaptive Directionality, Tri-state Noise Reduction, Data Logging, and Learning Volume Control.
Here's a breakdown of the acceptance criteria and study information for the Oticon Medical Ponto Pro Power bone-anchored sound processor, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily established through substantial equivalence to predicate devices, particularly the Baha Intenso (K081606). The device performance is verified through bench testing and clinical evaluation comparing it to the predicate.
| Characteristic | Acceptance Criteria (Predicate: Baha Intenso K081606) | Reported Device Performance (Ponto Pro Power) | Device Meets Criteria? |
|---|---|---|---|
| Indications for Use | Improvement of hearing for patients with conductive and mixed hearing losses, bilateral fitting, and single-sided deafness. | Equivalent indications for use. | Yes |
| Pure tone average bone conduction threshold (conductive/mixed hearing loss) | Better than or equal to 55 dB HL (measured at 0.5, 1, 2, 3 kHz) | Verified to successfully fit the same patient population, i.e., those with bone-conduction thresholds of |
§ 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.