(125 days)
The Cochlear Baha 7 Sound Processor is intended for the following patients and indications for use:
- Patient of any age for use with the Baha SoundBand, Baha Softband (or headband) or Baha SoundArc. Patients aged 5 and older for use with the Baha auditory osseointegrated implant system.
- Patients who have a conductive or mixed hearing loss and can still benefit from sound amplification. The pure tone average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3kHz) should be better than or equal to 55 dB HL.
- Bilateral fitting is intended for patients who meet the above criterion in both ears, with bilaterally symmetric moderate to severe conductive or mixed hearing loss. Symmetrical bone-conduction thresholds are defined as less than a 10 dB average difference between ears (measured at 0.5, 1, 2, and 3 kHz), or less than a 15 dB difference at individual frequencies.
- Patients who suffer from unilateral sensorineural deafness in one ear with normal hearing in the other ear (i.e. Single-sided deadness: SSD). Normal hearing is defined as a pure tone average air-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 20 dB HL.
- Baha for SSD is 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 Cochlear Baha bone conduction hearing system provides an alternate solution for patients who may not benefit from air-conduction hearing aids. Unlike air-conduction hearing aids, the Baha implant system utilizes a natural bone conduction pathway to send sound directly to the inner ear (cochlea), bypassing a damaged outer or middle ear. The Baha bone conduction hearing system has non-surgical and surgical options. For the non-surgical option, the external sound processor, which converts acoustic sound into mechanical vibrations, is securely placed behind the ear with a Baha SoundBand, Baha Softband, or Baha SoundArc. For the surgical option, the external sound processor is coupled with an abutment (Baha Connect) or magnet (Baha Attract). The mechanical vibrations travel through the abutment or magnet to a small, titanium implant, which is surgically placed into the bone. The titanium implant has an osseointegrated bond with the surrounding bone, allowing transmission of high-quality sound directly to the inner ear.
The Baha 7 Sound Processor is a firmware variant of the previously cleared Baha 6 Max Sound Processor (K202048). The changes introduced in this 510(k) are specific to the sound processor and accessories, and do not affect the cleared Baha Connect abutments, Baha Attract magnet, the BI300 titanium implant, Baha Softband, or Baha SoundArc. The Baha 7 Sound Processor does not modify the intended functionality or fundamental operating principles of the bone conduction hearing system. The changes within culminate as the next generation Baha sound processor that supports Bluetooth LE Audio streaming, which enables compatibility with the new generation wireless accessories from GN Hearing.
The Baha 7 Sound Processor will be supported by a new fitting software (Baha Fitting Software 7), an updated app (Baha Smart App), and a new non-surgical retention option (Baha SoundBand).
The provided text describes a 510(k) premarket notification for the Cochlear Baha 7 Sound Processor. It focuses on demonstrating substantial equivalence to a predicate device, the Baha 6 Max Sound Processor. While it mentions various types of testing conducted (biocompatibility, software, electromagnetic compatibility, and bench testing), it does not include specific acceptance criteria or detailed study results for device performance in the format requested.
The document primarily provides:
- A summary of the device and its components (Baha 7 Sound Processor, Baha Fitting Software 7, Baha Smart App, Baha SoundBand).
- Indications for Use.
- A comparison table (Table 1, 2, 3, 4) detailing similarities and differences between the new device and the predicate(s).
- A general statement about performance data: "The testing demonstrated that the software supported the clinician fitting and recipient control of the Baha 7 Sound Processor." and "The bench testing demonstrates that the Baha 7 SP does not result in additional safety or efficacy concerns in comparison to the predicate." and "The results demonstrated the Baha 7 Sound Processor is functionally equivalent to the Baha 6 Max Sound Processor."
Therefore, based on the provided text, it is not possible to fully answer your request regarding specific acceptance criteria, reported device performance in a table, sample sizes, ground truth establishment details, or MRMC study results because this information is not present in the excerpt. The document focuses on demonstrating substantial equivalence through feature comparison and general statements about testing, rather than presenting a performance study with quantitative acceptance criteria and results.
Here's what can be inferred or stated based on the provided text, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Inferred/Missing) | Reported Device Performance (General Statement from Text) |
|---|---|
| Specific quantitative thresholds for functional and performance metrics (e.g., sound output, frequency response, battery life, signal-to-noise ratio). | "The results demonstrated the Baha 7 Sound Processor is functionally equivalent to the Baha 6 Max Sound Processor." |
| Specific quantitative thresholds for software function (e.g., successful programming rate, app connectivity stability). | "The testing demonstrated that the software supported the clinician fitting and recipient control of the Baha 7 Sound Processor." |
| Specific quantitative thresholds for EMC compliance. | "Electromagnetic compatibility testing established that the sound processor did not emit excessive amounts of electromagnetic energy, and that it operated as intended in the presence of interference sources." |
| Specific thresholds for biocompatibility (e.g., passing ISO 10993-1 tests). | "Biocompatibility evaluation and testing demonstrated that the materials, packaging residuals, and the input from the manufacturing process are biocompatible." |
| Specific criteria for reliability and environmental testing. | "Bench functionality and performance testing included functional and performance testing, hardware and interface testing, reliability and environmental testing, as well as system and subsystem level testing." |
2. Sample size used for the test set and the data provenance:
- Not specified. The document mentions "bench functionality and performance testing" and "software testing" but provides no details on the sample size of devices or the data used for these tests.
- Data Provenance: Not specified for any performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This type of information is typically relevant for studies involving human assessment (e.g., diagnostic accuracy studies for AI in imaging). As the device is a hearing aid sound processor, and the submission focuses on functional equivalence, there is no mention of "ground truth" adjudicated by experts in this context within the provided text. The "ground truth" for the device's function would be its measured physical characteristics and software performance against specifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. Not applicable given the nature of the device and the type of information presented. Adjudication methods are typically used in clinical studies or AI performance evaluations where human interpretation or consensus is required to establish a definitive ground truth.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC study was not done or is not reported here. This type of study is primarily relevant for AI-powered diagnostic aids where human readers interpret medical images or data. The Baha 7 Sound Processor is a hearing aid sound processor, not an AI diagnostic tool for human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, implied. The "functional and performance testing, hardware and interface testing, reliability and environmental testing" would be considered standalone testing of the device and its software. The document states, "The results demonstrated the Baha 7 Sound Processor is functionally equivalent to the Baha 6 Max Sound Processor," which is a statement about its standalone performance. However, no specific metrics or detailed results of this standalone testing are provided beyond this general statement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Instrumental measurements and compliance with specifications. For a device like a sound processor, the "ground truth" for performance would be established through calibrated laboratory instruments measuring audio output, frequency response, power consumption, signal processing accuracy, and electromagnetic emissions, compared against engineering specifications and regulatory standards. Biocompatibility is assessed against ISO 10993. Software functionality is tested against design requirements. The text confirms
- "Biocompatibility evaluation and testing demonstrated that the materials... are biocompatible." (Ground truth: ISO 10993 standards and lab tests).
- "Software testing was performed... demonstrated that the software supported the clinician fitting and recipient control of the Baha 7 Sound Processor." (Ground truth: Software specifications and functional requirements).
- "Electromagnetic compatibility testing established that the sound processor did not emit excessive amounts of electromagnetic energy, and that it operated as intended in the presence of interference sources." (Ground truth: EMC standards).
- "Bench functionality and performance testing... demonstrates that the Baha 7 SP does not result in additional safety or efficacy concerns in comparison to the predicate." (Ground truth: Engineering specifications and direct comparison to predicate device performance).
8. The sample size for the training set:
- N/A. This device does not appear to involve machine learning models that require a "training set" in the context of typical AI device submissions for diagnostic or predictive purposes. The software mentioned (Baha Fitting Software 7, Baha Smart App) are control and interface applications, not described as adaptive or learning algorithms that require large training datasets.
9. How the ground truth for the training set was established:
- N/A. As no training set for an AI model is indicated, this question is not applicable.
§ 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.