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The Unity 2 HIA and Probe are intended to be used as a system to: (1) perform Real Ear Measurement; (2) get an objective indication of the characteristics of a hearing aid; and (3) assist in the adjustment of hearing aids while in use by the patient. It is used by ENTprofessionals and in clinics for hearing aid fitting.

Siemens Unity 2 HIA and Probe (for use with Siemens Unity 2 System)

The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is an FDA 510(k) clearance letter for the Siemens Unity 2 HIA and Probe, indicating it has been found substantially equivalent to a legally marketed predicate device.

Therefore, I cannot provide the requested table or details about a study.

The document only states the "Indications For Use" for the device, which are:

1. Perform Real Ear Measurement.
2. Get an objective indication of the characteristics of a hearing aid.
3. Assist in the adjustment of hearing aids while in use by the patient.

It also mentions that the device is used by ENT professionals and in clinics for hearing aid fitting.

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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:

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.

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To amplify and transmit sound to the ear. The VITA 160 Series Pocket Hearing Instruments (Models 162E, 166M and 168PP) are designed to provide amplification for a wide range of hearing losses, from moderate to profound.

Body (Pocket) Hearing Aid - Substantially equivalent to other Body worn (Pocket) hearing aids. Sound is transmitted from the body-worn amplifier to a non-custom earpiece through a standard electrical earphone cable. The VITA 162E and 166M medium power models both provide 132dB peak output and 65dB peak gain. They include a telecoil with O-T-M switch (Off-Telecoil-Microphone) and an Audio Input socket. The VITA 166M medium power model additionally provides two controls for the dispenser to adjust: Low Frequency Tone (NH) and Maximum Power Output (PC). The VITA 168PP high power model provides 142dB peak output and 79dB peak gain. It includes a telecoil with O-T-M switch (Off-Telecoil-Microphone) and an Audio Input socket. Three controls are provided for the dispenser to adjust: Low Frequency Tone (NH),Gain and Output Compression (AGC-O). Assembled from standard components which are widely utilized by other hearing aid manufacturers. Technical specifications comply with S3.22-1987 ANSI Specifications. The frequency response of the product is included. Some adjustments may be made by the dispenser to adjust the amplification to the audiogram of the patient. User controls include an adjustable volume control wheel and an M-T-O 3 position toggle switch. Uses one standard AA Size battery.

This document, K962176, is a Premarket Notification (510(k)) for the Siemens VITA 160 Series Pocket Hearing Instruments, submitted to the FDA in 1996. It details the device's intended use, features, and technical characteristics to demonstrate substantial equivalence to other legally marketed body-worn hearing aids.

However, this document does not contain the type of information requested regarding acceptance criteria and a study proving the device meets those criteria.

Here's why and what's missing:

• Focus of a 510(k): A 510(k) submission primarily focuses on demonstrating "substantial equivalence" to a predicate device already on the market. This often involves showing similar technological characteristics and performance specifications. It typically does not include a detailed clinical study with pre-defined acceptance criteria, especially for a device type like a hearing aid from 1996.
• Nature of the Device: Hearing aids amplify sound. Their "performance" is generally assessed by their acoustic output and how well they meet specifications like gain, frequency response, and maximum output. The concept of "acceptance criteria" for diagnostic accuracy (common in AI or imaging devices) is not applicable here.
• Information Provided:
  • "Technical Characteristics: Technical specifications comply with S3.22-1987 ANSI Specifications." This is the closest thing to a performance standard. It indicates that the device's acoustic properties (e.g., gain, frequency response, output) meet the industry standard at the time. However, it's not a study report with acceptance criteria.
  • No clinical study described: There is no mention of a study involving human subjects, a test set, ground truth, experts, or statistical analysis of performance outcomes against specific criteria.

Therefore, I cannot populate the requested table and details because the provided document does not contain this information. The K962176 is a notification of substantial equivalence based on technical specifications and comparison to predicate devices, not a report of a study designed to demonstrate performance against specific, pre-defined acceptance criteria with a designated test set and ground truth.

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