(135 days)
The Cochlear Baha Connect System (Baha sound processors and implant/abutment system) is intended for the following patients and indications for use:
- Patients aged 5 and older
- 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 45 dB HL for use with the Baha 4 and Baha 5 sound processors, 55 db HL for use with the Baha 5 Power sound processors, and 65 db HL for use with the Baha 5 SuperPower Sound Processors.
- 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-conductive 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 15dB 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 deafness: 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.
Specific models of the Cochlear Baha abutments can be used with either the Cochlear Baha Connect System or compatible sound processors from Oticon Medical AB. Refer to the Cochlear Baha abutment labeling for a list of compatible Oticon Medical sound processors.
A bone anchored hearing system consists of a sound processor connected to an implant with a skin penetrating abutment. The implant is surgically anchored in the skull bone behind the ear. Vibrations generated by the sound processor are transmitted via the implant directly through the skull bone to the cochlea as bone conduction sound. The BA310 abutments are modifications of the previously cleared BA300 abutments and provide additional sound processor compatibility than the previously cleared abutments. Compared to the currently cleared BA300 and BA400 Abutments, a small "flange" has been added to the upper part of the BA310 Abutment and the core diameter of the abutment has been reduced by 0.7mm. This design allows sound processors from Oticon Medical to snap on the outside of the abutment while maintaining the same snap in coupling design for connection to Baha sound processors.
This document describes the premarket notification for the Cochlear BA310 Abutment and BIA310 Implant/Abutment, a bone-conduction hearing implant system. The submission focuses on demonstrating substantial equivalence to predicate devices, particularly regarding a design modification to the abutment.
Here's an analysis based on your request, highlighting what information is present and absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was tested for?) | Reported Device Performance (Was it met?) |
|---|---|
| Compatibility between Oticon Medical Ponto sound processors and BA310/BIA310 abutments/implants | Verified |
| Compatibility between Cochlear Baha sound processors and BA310/BIA310 abutments/implants | Verified |
| Rotation torque of the coupling connection | Tested and verified |
| Snap force of the coupling connection | Tested and verified |
| Bend force of the coupling connection | Tested and verified |
| Frequency testing of the coupling connection | Tested and verified |
| Mitigation of surgical procedure impact due to design change | Mitigated through labeling recommendations |
| Mitigation of soft tissue reaction due to closer contact of Oticon sound processors | Mitigated through labeling recommendations |
| Overall safety and effectiveness | Demonstrated as safe and effective |
Gaps in information: The document states that performance data "verifies the compatibility" and that "All design requirements were met," but it does not provide specific numerical acceptance criteria (e.g., a minimum rotation torque value) or the quantitative results from the tests. It broadly indicates that the relevant parameters were "tested and verified."
2. Sample Size Used for the Test Set and the Data Provenance
Sample Size for the test set: Not specified. The document mentions "non-clinical testing and analysis" but does not detail the number of units or conditions tested.
Data Provenance: Not specified. Given it's a non-clinical/bench testing study for a medical device modification, the data would typically originate from a laboratory setting. It is not a clinical study involving human patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable and not provided. The "ground truth" concept, in this context, would typically refer to clinical diagnosis or outcome verification against which an AI algorithm's performance is measured. This document describes bench testing of a physical device modification, not an AI algorithm.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used in clinical studies or expert review processes, typically for establishing ground truth for diagnostic accuracy, which is not what this submission is about.
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
This information is not applicable and not provided. This submission concerns a physical medical device (a hearing implant abutment) and its bench testing, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance is irrelevant here.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This information is not applicable and not provided. This document does not describe an algorithm or AI device; it describes a mechanical component of a hearing aid system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable and not explicitly defined in the context of "ground truth" as typically used for AI/diagnostic studies. For this device modification, the "ground truth" would be the engineering specifications and functional requirements for the abutment's mechanical performance and compatibility. The document states that "All design requirements were met," implying these engineering specifications served as the "ground truth" for the non-clinical tests.
8. The Sample Size for the Training Set
This information is not applicable and not provided. This is not an AI/machine learning study, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided. As there is no training set, the establishment of its ground truth is irrelevant.
§ 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.