(114 days)
The Cochlear™ Baha® 5 SuperPower Sound Processor is intended for treatment of patients who have conductive or mixed hearing loss as a result of certain medical conditions such as bilateral atresia and chronic supportive otitis media, and for those who have Single-Sided Deafness (SSD) caused by a congenital condition, surgery, trauma, or disease.
The Cochlear™ Baha® 5 SuperPower Sound Processor has the following indications for use:
• Patients of any age for use with the Baha Softband or headband. 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 3 kHz) should be better than or equal to 65 dB HL.
· Bilateral fitting is intended for patients who meet the criterion in both ears, with bilateral 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 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.
The Cochlear™ Baha® 5 SuperPower Sound Processor functions by combining the external sound processor with an abutment and a small titanium implant placed that is placed in the skull behind the ear through a simple surgical procedure. The sound processor transmits acoustic signals into electrical signals when then causes mechanical action in the transducer to transmit sound transcranially to the functioning auditory system. The Baha system combines an external sound processor, in this application the Cochlear™ Baha® 5 SuperPower Sound Processor, with an abutment and small titanium implant placed into the bone through a simple surgical procedure. The implant subsequently forms an osseointegrated bond with the surrounding bone, allowing transmission of high-quality sound directly to the inner ear, bypassing a damaged outer or middle ear. The Baha system provides an alternate pathway for patients who may not benefit from wearing an air-conduction hearing aid. The changes introduced in this 510(k) are specific to the sound processor, not the abutment/implant or magnet. These changes culminate as the next generation Baha sound processor that provides recipients with moderately severe hearing loss (up to 65dB SNHL) access to sound. The Cochlear™ Baha® 5 SuperPower Sound Processor includes a decoupling of the microphone/processor and the actuator unit to allow various wearing options. The wearing options allow the recipient to achieve maximum gain while minimizing the likelihood of feedback. The design has been modified to incorporate a new rechargeable lithium-ion battery pack which provides the power needed for recipients with up to 65dB SNHL measured by pure tone average bone-conduction hearing thresholds at 0.5, 1, 2, and 3 kHz. This change does not modify the intended functionality or fundamental operating principles of the implant/abutment system.
The provided text describes the Cochlear™ Baha® 5 SuperPower Sound Processor and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the format requested.
The document is a 510(k) premarket notification for a medical device (a hearing aid). In a 510(k) submission, the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving performance against pre-defined acceptance criteria in the same way a de novo or PMA submission might.
Here's a breakdown of why the requested information cannot be fully extracted and what is available:
What the document does provide:
- Device Name: Cochlear™ Baha® 5 SuperPower Sound Processor
- Intended Use: Treatment of patients with conductive or mixed hearing loss, or Single-Sided Deafness (SSD).
- Indications for Use: Detailed criteria for patient age, hearing thresholds (bone-conduction and air-conduction), and conditions for bilateral fitting or SSD. These essentially are the "acceptance criteria" for patient selection and device applicability, not performance criteria of the device itself.
- Predicate Devices: Cordelle II Sound Processor (K150751) and Baha 5 Sound Processor (K142907).
- Performance Data Mentioned: "Performance testing was conducted to compare the Cochlear™ Baha® 5 SuperPower Sound Processor with the predicate implant / abutment systems. Substantial equivalence to the predicate device was accomplished through environmental testing, reliability and durability testing, electrical interface testing, and functional and performance testing. The results demonstrated the Cochlear™ Baha® 5 SuperPower Sound Processor is functionally equivalent to the predicate devices."
Why the requested table and study details cannot be filled from the provided text:
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A table of acceptance criteria and the reported device performance:
- The document lists indications for use, which are criteria for patient eligibility and how the device should be used, not performance metrics of the device itself (e.g., sound quality, gain, battery life, speech understanding scores). There are no specific numerical performance targets (e.g., "device shall achieve a 10 dB improvement in speech recognition score") and no corresponding measured performance values.
- The "performance testing" mentioned is general and aimed at demonstrating "functional equivalence" to predicate devices, but the specific metrics, acceptance thresholds, and measured results are not provided.
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Sample size used for the test set and the data provenance: Not mentioned.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or mentioned. The "performance testing" described is likely engineering/technical testing rather than human-expert-based clinical evaluation for establishing ground truth as one might see in an AI/diagnostic device.
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Adjudication method for the test set: Not applicable or mentioned.
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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: Not applicable. This is not an AI/diagnostic device that relies on human readers interpreting outputs. It's a hearing aid.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable in the context of an AI algorithm, as this is a physical medical device. The device's "standalone" performance is its function as a hearing aid, which is what the general "functional and performance testing" refers to, but without specifics.
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The type of ground truth used: For the purposes of a 510(k) for a hearing aid, "ground truth" would relate to the objective physical and acoustical performance characteristics (e.g., output sound pressure level, frequency response, distortion, battery drain) and potentially clinical outcomes in human subjects (e.g., audiological tests). The document states "Substantial equivalence to the predicate device was accomplished through environmental testing, reliability and durability testing, electrical interface testing, and functional and performance testing," implying objective physical measurements were the "ground truth" for these engineering tests.
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The sample size for the training set: Not applicable. This is not a machine learning/AI device that requires a training set.
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How the ground truth for the training set was established: Not applicable.
Summary Table based on available information:
| Acceptance Criteria (from Indications for Use) | Reported Device Performance (Implied by Substantial Equivalence) |
|---|---|
| Patient Age: ≥ 5 years (for implant system); any age (for Softband/headband) | The device is deemed safe and effective for its intended use, which includes these age groups, through demonstrated substantial equivalence to predicate devices. |
| Hearing Loss Type: Conductive or mixed hearing loss | The device is functionally equivalent to predicate devices for treating these types of hearing loss. |
| Bone-Conduction Threshold (Conductive/Mixed): PTA ≤ 65 dB HL (at 0.5, 1, 2, 3 kHz) | The device provides the necessary amplification and sound transmission for patients meeting this criterion, as demonstrated by "functional and performance testing" and comparison to predicate devices, which also serve this patient population. The device is designed to provide "maximum gain" for recipients with up to 65dB SNHL. |
| Bilateral Fitting Criteria: Symmetric moderate to severe conductive or mixed hearing loss (average difference |
§ 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.