(292 days)
The Otomag Alpha I Sound Processor is intended for use with the Otomag Headband or Olomag Softband (no age limitations), or with the Otomag Osseointegrated Magnetic Implant (patients 5 years of age and up) 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 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 consists of two distinct configurations; Alpha 1 (S) and Alpha 1 (M). This 510(k) is being submitted to add the Alpha 1 (M) configuration to the existing product family.
In the Otomag 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.
In the Otomag Alpha 1 (M), the Otomag Sound Processor is attached magnetically to an implanted magnet assembly. The magnetic field holds the sound processor against the head and vibration is transduced through direct contact with the patient's skin and the bone below. A variety of magnetic spacers, each with a different magnetic strength, are provided with the Alpha 1(M) configuration to allow adjustment of the magnetic field strength that holds the sound processor against the head.
The magnetic implant of the system is provided clean and non-pyrogenic, but is not sterile. The implant is intended to be sterilization at the healthcare facility immediately prior to implementation.
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.
Here's an analysis of the acceptance criteria and study information for the Otomag Bone Conduction Hearing System, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
The 510(k) summary for the Otomag Bone Conduction Hearing System (K102199) does not explicitly state pre-defined acceptance criteria for its clinical performance in terms of specific thresholds for "Unaided Speech Understanding," "Aided Speech Understanding," "Free Field Gain," or "Aided Free Field Thresholds."
Instead, it presents the results of clinical performance testing for the modified device (Alpha 1(M)) configuration and highlights that these results, along with non-clinical testing, support its substantial equivalence to predicate devices. The implicit acceptance criterion appears to be that the device demonstrates safe and effective performance that is comparable to or better than previously cleared predicate devices, as evidenced by the reported outcomes.
Here's a table summarizing the reported clinical performance measures:
| Measure | Reported Device Performance (Mean and Stdev) |
|---|---|
| Unaided Air Conduction Thresholds | 54 +/- 12 dB |
| Unaided Bone Conduction Thresholds | 16 +/- 10 dB |
| Unaided Speech Understanding | 4 +/- 10 % |
| Aided Speech Understanding | 86 +/- 17 % |
| Free Field Gain | 38 +/- 8 dB |
| Aided Free Field Thresholds (calculated) | 16 dB |
The key non-clinical acceptance criteria were for:
- Device retention
- Vibration Transmission Comparison Alpha 1(M) vs. Alpha 1(S)
- Software Validation
- Sound Processor Performance: Frequency Response
- Immunity (IEC 60601-1-2)
- Implant Performance after 3x Sterilization
- Autoclave Cycle Performance (Sterilization)
- Accelerated Aging: Magnet Retention
- Dislodgement Force: Normal and Tangential
- Accelerated Aging: Screw Retention
The summary states that the testing demonstrated the device's performance is substantially equivalent to the predicate devices, indirectly indicating that the performance met the expected standards for these criteria.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size (Clinical Test Set): 86 Alpha 1(M) devices implanted into 57 patients.
- Data Provenance: Not explicitly stated regarding the country of origin. The study was prospective in nature, as it describes a "trial" with "mean follow up time for the study was 1.6 years from the time of implant, with a range of 0.5 years." This indicates data collection after the implantation of the devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The summary does not mention the use of experts to establish ground truth in the context of the clinical performance data (e.g., for speech understanding or audiological thresholds). These measurements are typically obtained objectively through standardized audiological testing procedures.
4. Adjudication Method for the Test Set:
Not applicable. The clinical performance data presented appears to be direct measurements rather than subjective assessments requiring adjudication. The adverse events (e.g., redness, infections) were reported as part of the trial, but no specific adjudication method for these events is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done for this device. The study focused on assessing the performance of the new Alpha 1(M) configuration in patients and comparing it to the performance parameters of predicate devices (Otomag Bone Conduction Hearing System, Unmodified Version - K100193 and Xomed Audiant Bone Conductor - K855059 / K861971) based on the principles of substantial equivalence. There is no mention of human readers or AI assistance in the context of this hearing system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a medical device (a bone conduction hearing system) and not an AI or algorithm-based diagnostic tool. The "Software Validation" refers to the programming software for the hearing aid, not a standalone AI diagnostic algorithm. The performance metrics are direct outcomes from the device's function in patients.
7. The Type of Ground Truth Used:
The "ground truth" for the clinical performance testing was based on objective audiological measurements (e.g., pure tone average thresholds, speech understanding scores) collected from the participating patients, as well as clinical observations and patient reports for adverse events and dislodgement issues.
8. The Sample Size for the Training Set:
Not applicable. This is a medical device, not an AI model that requires a training set in the conventional sense. The "Alpha 1(M)" configuration is a modification of an existing product, and its design and performance build upon established principles of bone conduction hearing systems.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for an AI model. The device's design and engineering are based on established medical and acoustical principles, and its safety and effectiveness are supported by non-clinical and clinical validation studies against pre-defined performance standards and comparison to predicate devices, rather than a "training set" with ground truth in the AI context.
§ 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.