(116 days)
The Otomag Alpha 1 Sound Processor is intended for use with the Otomag Headband or Otomag Softband (no age limitations) for the following patients and indications:
- Patients with conductive or mixed hearing losses, who can still benefit from amplification of sound. The pure tone average (PTA) bone conduction (BC) threshold for the indicated ear should be better than 45 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 10dB 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, who for some reason will not or cannot use an AC CROS. The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should be better than 20 dB HL (measured at 0.5, 1, 2 and 3 kHz).
The Otomag Alpha 1 (S) Sound Processor is intended to the Otomag Headband or Softband.
The Otomag Bone Conduction Hearing System is a family of sound processors and accessories that operate on the principle of bone conduction of sound vibrations.
The Otomag System called the Alpha 1 (S), the Otomag Sound Processor is attached magnetically to a headband or softband. The headband or softband holds the sound processor against the head and vibration is transduced through direct contact with the patient's skin and the bone below.
The Otomag System is designed for use for those patients with conductive hearing loss, those patients who have sensorineural hearing loss up to 45 dB in combination with their conductive loss, and single sided deafness as defined in the indications for use. The prescriptive formula and adjustments available to the audiologist in the software allow for programming the Otomag System for individual patient hearing loss.
The provided text describes the "Otomag Bone Conduction Hearing System" and its substantial equivalence determination, but it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria with numerical results or statistical analysis.
Instead, the document focuses on:
- 510(k) Summary: A declaration that the device is substantially equivalent to legally marketed predicate devices. This is a regulatory pathway that primarily relies on demonstrating similarity to existing devices rather than new performance studies against predefined acceptance criteria.
- Indications for Use: Details when and for whom the device is intended.
- Contraindications: Situations where the device should not be used.
- Summary of Technical Characteristics: States that the device's technical specifications are "substantially equivalent" to predicate devices.
- Summary of Non-Clinical Testing: States that testing "demonstrates the Otomag System’s performance is substantially equivalent to the predicate devices."
Therefore, based only on the provided text, I cannot complete the requested tables/information. There is no mention of:
- Acceptance criteria: Specific measurable thresholds the device needs to meet (e.g., a certain SNR, dB gain, or speech recognition score).
- Reported device performance: Actual numerical results from a study showing how the Otomag performs against any criteria.
- Sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone study, type of ground truth, training set size, or ground truth establishment for training set. These are all details typically found in a performance study report, which is not present in this 510(k) summary.
Conclusion based on the provided text:
The document asserts "substantial equivalence" based on technical specifications and non-clinical testing to predicate devices (Oticon Medical Ponto Pro Bone Anchored Sound Processor K090996 and Cochlear BAS Baha BP100 Sound Processor K090720). However, it does not provide the specific performance data or the detailed study design elements requested in your prompt. The focus is on regulatory equivalence rather than a detailed performance study with explicit acceptance criteria.
§ 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.