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510(k) Data Aggregation
(83 days)
The Baha Intenso™ sound processor is intended for use with the Baha auditory osseointegrated implant or Baha Headband for the following patients and indications:
- 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 55 dB HL.
- Bilateral fitting of the Intenso 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 deafness or "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 Baha implant system works by combining a sound processor with an abutment and a small titanium implant placed in the skull behind the ear. The system is based on the process of "osseointegration" through which living tissue integrates with titanium in the implant. Thus, the titanium implant becomes one with the bone, allowing high-quality amplified and processed sound to be conducted via the skull bone directly to a cochlea with residual functionality. The Baha implant is cleared for use in children aged 5 and older, and in adults.
The Intenso is one of three currently marketed sound processors for use with the Baha auditory osseointegrated implant. It is the highest gain ear-level sound processor currently available, although the maximum output is less than that for the high-power body-worn sound processor.
Baha sound processors, including the Intenso, can also be used with the Baha Headband (or Softband). In this application there is no implantation surgery: Rather, the sound processor is attached firmly to the head using either the hard or soft headband, and the amplified vibrational sound is transmitted transcutaneously to the bones of the skull for transmission to the cochlea. The Baha Headband is suitable for use in patients of all ages.
Baha Intenso™ is an external sound processor that utilizes digital signal processing with active feedback cancellation technology for use with the Baha auditory osseointerrated implant. It has substantially equivalent technology to previously marketed sound processors for the Baha system (Baha Compact, Baha Classic 300) and to the other two currently marketed Baha sound processors (Baha Divino, Baha Cordelle II). The external sound processors of the Baha system differ in style, signal processing, features, and degree of available gain and output, but they are all interchangeable in that they all snap onto the abutment of the Baha auditory osseointegrated implant. Choice of processor(s) depends on the individual needs and desires of the patient. The Intenso is often chosen for patients who have greater gain needs than can be met with the Divino (i.e. those with mixed losses and poorer bone-conduction hearing thresholds), but who want the cosmetic discretion of wearing an ear-level device rather than the bulkier body-worn Cordelle II.
Acceptance Criteria and Study for Baha® Intenso™
The Baha Intenso™ is a hearing aid (bone conduction) that was submitted for an expanded indication for use. The acceptance criteria and supporting study are outlined below:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Proposed Indication) | Reported Device Performance | Basis for Performance |
|---|---|---|
| Average four-frequency bone-conduction threshold ≤ 55 dB HL | The Baha Intenso™ demonstrates significantly higher gain/output than the Baha Divino™ but less maximum output than the Baha Cordelle II™. | Bench testing and comparison to predicate devices. |
2. Sample Size and Data Provenance for Test Set
- Sample Size: Not applicable. The submission for the expanded indication for the Baha Intenso™ did not involve a new clinical test set with human subjects. Instead, it relied on bench testing and a comparison of the device's gain/output characteristics to already-cleared predicate devices and their established clinical performance.
- Data Provenance: Not applicable for a new test set. The clinical performance data referenced for predicate devices (Baha Divino and Baha Cordelle II) were from published literature. The document does not specify the country of origin, but generally, published peer-reviewed literature would have undergone ethical review processes in their respective geographies. The studies referenced appear to be retrospective analyses of clinical outcomes or prospective observational studies of device users.
3. Number of Experts and Qualifications for Ground Truth for Test Set
Not applicable. As no new clinical test set was created for this specific submission, no external experts were used to establish ground truth for a new test set. The validation was based on the technical characteristics of the device and its position relative to established predicate devices.
4. Adjudication Method for Test Set
Not applicable. There was no clinical test set requiring adjudication in this submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was conducted for this submission. The basis for the expanded indication was primarily bench testing and inference from established devices.
6. Standalone (Algorithm Only) Performance
This device is not an algorithm-only device. It is a physical medical device (hearing aid). The "standalone" performance in this context would refer to its acoustic and mechanical performance characteristics, which were assessed via bench testing.
7. Type of Ground Truth Used
The "ground truth" for this submission was based on:
- Bench Testing Data: Objective measurements of the Baha Intenso™'s gain and output.
- Established Clinical Efficacy of Predicate Devices: Clinical outcomes data from published literature on the Baha Divino™ and Baha Cordelle II™. The premise is that if the Intenso's gain/output falls between these two devices, and they are effective for certain hearing loss ranges, then the Intenso should be effective for an intermediate range.
8. Sample Size for Training Set
Not applicable. This submission is for an expanded indication of an existing device, not a new device requiring a machine learning model with a training set. The device itself is a signal processing hearing aid, not an AI or algorithm-based diagnostic tool that would typically use a "training set" in the context of machine learning.
9. How Ground Truth for Training Set Was Established
Not applicable, as there was no training set in the typical sense for this device submission.
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