(205 days)
The devices are intended for the adult population suffering from a chronic persistent ringing in the ears (Tinnitus), who do not need or desire amplification. The products may be used for masking Tinnitus as part of a Tinnitus Retraining Therapy (TRT) protocol and should be utilized only in consultation with a licensed hearing healthcare professional, who is trained in subsequent rehabilitation therapy, or a qualified audiologist.
The audifon sueno devices are digital noise generators which were developed to be used in a tinnitus retraining therapy. These products have one program, which can be programmed in shape and level to fit the individual user's needs. The programming can be done with a standard HI-PRO and the audifit software. The noise can be adjusted in shape with low- and high-cut filters and in the output level. It is housed in a standard In-the-ear instrument housing (CIC housing) or in a standard behind-the-ear instrument housing (S housing). The audifon sueno T devices (sueno T S and sueno T CIC) can be additional adjusted with three trimmer potentiometers by the hearing healthcare professional.
The provided document does not describe a study that establishes acceptance criteria for the audifon sueno devices, nor does it provide performance data from such a study. Instead, the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device (audifon switch TRT, K091552).
Therefore, I cannot fill in the requested table and answer many of the questions directly. However, I can extract information related to the comparison with the predicate device, which serves as the basis for deeming the new device safe and effective.
Here's a summary based on the provided text:
Basis for Acceptance: The audifon sueno devices were accepted based on their substantial equivalence to the predicate device, audifon switch TRT (K091552). This means the FDA determined that the new devices are as safe and effective as the predicate device, and perform as well. This determination relies on comparing design, materials, intended use, targeted population, and non-clinical performance data (acoustic characteristics).
Key Information from the Document:
1. Table of Acceptance Criteria and Reported Device Performance (as inferred from the substantial equivalence comparison):
It's important to note that the "acceptance criteria" here are not a set of predefined performance thresholds for a clinical study. Instead, they are the characteristics and performance aspects compared to the predicate device for demonstrating substantial equivalence. The "reported device performance" refers to the characteristics of the new device that align with or are justified against the predicate.
| Characteristic / "Acceptance Criteria" (Compared to Predicate) | Audifon Sueno Devices (Reported Performance/Characteristics) | Audifon Switch TRT (Predicate Device Characteristics) |
|---|---|---|
| Intended Use | The devices are intended for the adult population suffering from a chronic persistent ringing in the ears (Tinnitus), who do not need or desire amplification. The products may be used for masking Tinnitus as part of a Tinnitus Retraining Therapy (TRT) protocol and should be utilized only in consultation with a licensed hearing healthcare professional, who is trained in subsequent rehabilitation therapy, or a qualified audiologist. | The device is addressed to the adult population with a chronic persistent ringing in the ears (Tinnitus), who do not need or desire amplification. It may be used for masking tinnitus as part of tinnitus management program that is prescribed by a licensed hearing healthcare professional, who is trained in subsequent rehabilitation therapy, or a qualified audiologist. Therefore it generates a broadband noise with sufficient bandwidth and intensity and is applied on the ear. |
| Operation / Mechanism | Uses broadband noise; Manages tinnitus through masking and distraction. Circuit type: Digital. Programmable: Yes. Available noises: One. Volume control: Yes (white-noise is adjustable, noise level is programmable, adjustable Low Battery Indicator). | Uses broadband noise; Manages tinnitus through masking and distraction. Circuit type: Digital. Programmable: Yes. Available noises: Four. Volume control: No (white-noise is adjustable, noise level is programmable, adjustable Low Battery Indicator, programmable Program Switch Tones). |
| Physical Description | Standard In-the-ear instrument housing (CIC housing); Standard behind-the-ear instrument housing (S housing). | Standard receiver-in-the-ear instrument housing. |
| Maximum Output Characteristics (RMS) | White noise: sueno CIC 70 dB SPL, sueno S 92 dB SPL, sueno T CIC 71 dB SPL, sueno T S 72 dB SPL. (Note: "The lower maximum output has no influence on the effectiveness of the devices" because only levels below 80 dB SPL are needed for TRT, and OSHA limits are 85 dBA. | White noise: 100 dB SPL |
| Frequency Range | 200 - 8000 Hz | 200 - 6000 Hz (Note: "The frequency range provides an equivalent white noisewith the same sound quality.") |
| Power Source | standard 10 zinc air 1.4V hearing aid battery (CIC housing); standard 312 zinc air 1.4V hearing aid battery (S housing). | Uses standard 312 zinc air 1.4V hearing aid battery. |
| Quality Assurance | ANSI S3.22-2009 to ensure proper functioning of HA. | ANSI S3.22-2009 to ensure proper functioning of HA. |
| Similarity Conclusion | Similar acoustic characteristics, similar style (ITE or BTE), similar material, similar intended use, same targeted population. | (Basis for comparison) |
Regarding the Study Details:
The provided text describes a non-clinical performance data study to verify that the sueno devices have similar effectiveness to the predicate device, specifically measuring according to ANSI S3.22-2009. This is a standalone (algorithm only without human-in-the-loop performance) type of evaluation focusing on technical specifications rather than user interaction or clinical outcomes.
- 2. Sample size used for the test set and the data provenance: Not applicable. This was a non-clinical, technical performance test of the device's acoustic characteristics according to a standard, not a clinical study with a test set of human subjects or data. The data provenance would be from laboratory measurements in Germany (where audifon GmbH & Co. KG is located).
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a clinical dataset is not relevant to this type of non-clinical, technical performance testing.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 MRMC study was done. The device is a tinnitus masker, not an AI diagnostic tool for "human readers."
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, a standalone (non-clinical, technical performance) evaluation was done to measure acoustic characteristics according to ANSI S3.22-2009.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical performance test, the "ground truth" would be the specifications and requirements defined by the ANSI S3.22-2009 standard for hearing aids. The device's measured acoustic characteristics were compared against these standards and the known characteristics of the predicate device.
- 8. The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
- 9. How the ground truth for the training set was established: Not applicable.
In summary: The acceptance of the audifon sueno devices was based on a demonstration of substantial equivalence to an existing predicate device (audifon switch TRT) through non-clinical performance testing (acoustic characteristics measurement according to ANSI S3.22-2009) and comparison of their intended use, design, and materials. No clinical studies involving human subjects or AI performance evaluations against expert-established ground truth were performed or referenced in this 510(k) summary.
§ 874.3400 Tinnitus masker.
(a)
Identification. A tinnitus masker is an electronic device intended to generate noise of sufficient intensity and bandwidth to mask ringing in the ears or internal head noises. Because the device is able to mask internal noises, it is also used as an aid in hearing external noises and speech.(b)
Classification. Class II. The special control for this device is patient labeling regarding:(1) Hearing health care professional diagnosis, fitting of the device, and followup care,
(2) Risks,
(3) Benefits,
(4) Warnings for safe use, and
(5) Specifications.