(75 days)
Ponto 5 Mini sound processors are intended for the following patients and indications:
- Patients 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 5 Mini 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.
The placement of a bone anchored implant is contraindicated for patient below the age of 5.
The Ponto sound processors are intended to be used with either the Ponto implant system or with specific compatible Baha abutments/implants from Cochlear Bone Anchored Solutions (BAS) (refer to the Ponto labeling for specific compatible Cochlear models). In addition, selected Cochlear Baha sound processors can be used with the Ponto implant/abutment system (refer to the Ponto labeling for compatible Baha sound processor models).
The Ponto Bone Anchored Hearing System consists of an external sound processor unit and an implant with a skin penetrating abutment. The implant with the abutment is 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. The sound processor can be connected and disconnected by the snap coupling.
Ponto 5 Mini is a further development of the Ponto 4, cleared in K190540.The main difference between Ponto 5 Mini and Ponto 4 is a modification to the firmware in the Ponto 5 sound processors to additionally include the sound processing feature OpenSound™ Optimizer and an added compatibility with Oticon RemoteCare App from SBO Hearing A/S. Other than the minor changes to the firmware and compatibility, the technological characteristics of the Ponto 5 sound processors remain unchanged from the original design (most recently cleared in K190540).
Additionally, minor modifications to the accessory Genie Medical BAHS fitting software are made (e.g., added compatibility with Oticon RemoteCare App, addition of special purpose programs, and inclusion of DSL BC).
The provided text does NOT describe an AI/ML powered medical device, an acceptance criteria table, a study proving the device meets the acceptance criteria (except for performance data of an existing device), sample sizes for test/training sets, or details about establishing ground truth by experts. The document is an FDA 510(k) clearance letter for a hearing aid and focuses on substantial equivalence to a predicate device.
Therefore, I cannot answer the request with the information provided. The document outlines:
- Trade/Device Name: Ponto 5 Mini (a hearing aid)
- Predicate Device: Ponto 4
- Key Differences: Modification to firmware to include OpenSound™ Optimizer and compatibility with Oticon RemoteCare App.
- Performance Data: States "Electroacoustic verification includes Maximum output responses, Output for full-on gain at 50 dB SPL and 60 dB SPL, Equivalent input noise level, Total harmonic distortion, Frequency range, Battery voltage, Current Consumption, Battery lifetime, IRIL (input related interference level) and Processing delay. The results were according to requirements and equivalent to the performance of the predicate device, Ponto 4." It also mentions "same electrical and mechanical safety, electromagnetic compatibility (EMC), and radio properties and performance, that was established for the predicate, Ponto 4."
Since the request is about an AI/ML powered device and its validation study, this document does not contain the necessary information.
§ 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.