(24 days)
A wearable sound-amplifying device that is intended to help compensate for impaired hearing. Sounds are electronically amplified and transmitted to the ear.
PRISMA Behind the Ear and Custom Hearing Instruments are digitally programmable instruments. The dispenser programs the instrument using Siemens PC CONNEXX software with HiPro ™ hardware (K942749), Siemens Personal Programmer 2000, or UNITY with HiPro hardware This device is intended to compensate for a wide range of moderate to severe hearing losses including flat, ski-slope and reverse slope losses. It features digital control of a highly flexible digital signal processor. Up to 32 digitally adjustable parameters and two listening situations (memories) are accessible to shape and modify the instrument's response, depending on the model configuration. These include: Channel Delineation, Curvilinear Compression, Linear Compression, Syllabic Compression, Dual Compression, Voice Activity Detection System, Channel Gain, Cross Channel Shaping, Interchannel coupling, Twin Microphone System/Direction Mic, Low level Squelch, Second Program. Assembled from standard components that are widely utilized by other hearing aid manufacturers. Technical specifications comply with s3.22-1987 ANSI Specifications. The frequency response of the product is dictated by the individual Audiogram from each client and the settings of the programmable controls. User adjustable controls may be found on the Behind-the-Ear model which include a Microphone-Telecoil-Off (M-T-O) switch, and a momentary push-button switch to change between the two stored memories. Depending on the specific configuration of the instrument as ordered by the hearing instrument professional, some of these user controls may not be present. With the custom products, PRISMA comes standard with no user adjustable controls unless specifically requested by the hearing instrument professional, in which case a push button switch and/or directional microphone is available.
This document is a 510(k) premarket notification for the Siemens PRISMA Digital Hearing Aid. The primary purpose of a 510(k) is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific performance criteria through a study with acceptance criteria.
Therefore, many of the requested elements for a study demonstrating acceptance criteria are not applicable to this type of regulatory submission. The document explicitly states that the device is "substantially equivalent to other Behind the Ear (BTE) and Custom hearing aids... on the market" and that "Technical specifications comply with s3.22-1987 ANSI Specifications." This implies that the device is expected to meet the performance standards set by the ANSI specification, but no specific study demonstrating this against acceptance criteria is described in the provided text.
Here's an breakdown of the requested information based on the provided text, highlighting what is not applicable to a 510(k) for a hearing aid of this nature:
1. Table of Acceptance Criteria and Reported Device Performance:
A table of explicit acceptance criteria and reported device performance from a specific study is not provided in this 510(k) summary. The document states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with s3.22-1987 ANSI Specifications for hearing aids | "Technical specifications comply with s3.22-1987 ANSI Specifications" |
| Functionality as a digitally programmable hearing aid | "PRISMA Behind the Ear and Custom Hearing Instruments are digitally programmable instruments." |
| Compensation for a wide range of moderate to severe hearing losses | "This device is intended to compensate for a wide range of moderate to severe hearing losses including flat, ski-slope and reverse slope losses." |
| Ability to amplify and transmit sound to the ear | "A wearable sound-amplifying device that is intended to help compensate for impaired hearing. Sounds are electronically amplified and transmitted to the ear." (Intended Use) |
| Ability to be programmed via Siemens PC CONNEXX software with HiPro hardware, Siemens Personal Programmer 2000, or UNITY with HiPro hardware | "The dispenser programs the instrument using Siemens PC CONNEXX software with HiPro ™ hardware (K942749), Siemens Personal Programmer 2000, or UNITY with HiPro hardware" |
| Incorporate features such as channel delineation, curvilinear compression, voice activity detection, etc. | "It features digital control of a highly flexible digital signal processor. Up to 32 digitally adjustable parameters and two listening situations (memories) are accessible to shape and modify the instrument's response... These include: Channel Delineation, Curvilinear Compression, Linear Compression, Syllabic Compression, Dual Compression, Voice Activity Detection System, Channel Gain, Cross Channel Shaping, Interchannel coupling, Twin Microphone System/Direction Mic, Low level Squelch, Second Program." |
| User adjustable controls (on BTE model) including Microphone-Telecoil-Off (M-T-O) switch and momentary push-button | "User adjustable controls may be found on the Behind-the-Ear model which include a Microphone-Telecoil-Off (M-T-O) switch, and a momentary push-button switch to change between the two stored memories." |
| Power from standard hearing aid batteries | "Standard Hearing Aid Batteries: 5A,10A, 13, 312 and 675" |
2. Sample size used for the test set and the data provenance:
- Not applicable for this 510(k) submission. The document does not describe a clinical study or performance testing with a specific "test set" and associated sample size or data provenance in the context of demonstrating adherence to performance acceptance criteria. The claim is for substantial equivalence to existing devices and compliance with ANSI standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. As no specific "test set" for performance evaluation is described, there is no mention of experts establishing ground truth for such a set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No test set or expert adjudication is described.
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:
- Not applicable. This device is a hearing aid, not an AI-powered diagnostic or interpretive system that would involve "human readers" or "AI assistance" in the sense of an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This question is typically relevant for AI/algorithm-based diagnostic devices. The Siemens PRISMA is a hearing aid, whose performance is inherent in its electroacoustic properties and its ability to amplify sound for a user, as adjusted by a dispenser. Its "performance" is functional, not algorithmic in the context of standalone diagnostic capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No specific ground truth is described for performance evaluation. The device's "ground truth" for efficacy is implicitly its ability to meet the ANSI standards and amplify sound as intended for individuals with hearing loss, which is assessed through standard audiological practices rather than a 'ground truth' for an AI model.
8. The sample size for the training set:
- Not applicable. This device is hardware with digital programming capabilities, not a machine learning model developed with a training set.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set or its associated ground truth is relevant or mentioned for this device.
In summary: The provided document is a 510(k) premarket notification affirming substantial equivalence and compliance with established ANSI standards for hearing aids. It does not contain a detailed study proving the device meets specific acceptance criteria in the manner that a clinical trial or AI performance study would. The acceptance criteria are implicitly the ANSI standards and the device's functional characteristics typical of its predicate devices.
§ 874.3300 Air-conduction hearing aid.
(a)
Identification. An air-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. An air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. The air-conduction hearing aid generic type excludes the group hearing aid or group auditory trainer, master hearing aid, and the tinnitus masker, regulated under §§ 874.3320, 874.3330, and 874.3400, respectively.(b)
Classification. Class I (general controls). This device is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 874.9.