The Articulate G1 Series Hearing Aids are wearable, sound-amplifying devices that are intended to compensate for impaired hearing. The intended use of the Articulate series hearing aids is identical to that of the legally marketed predicate devices.

Device Description

The Articulate G1 Series Hearing Aids amplify and deliver sounds via air conduction to the external ear of persons with hearing losses. The microphone transforms sound waves into electrical signals and delivers it to the hearing aid circuit, which is powered by the battery. In the non-programmable Articulate models, the potentiometers of the circuit are used by the hearing aid dispenser to manually modify the amplification characteristics of the incoming signal. In the programmable Articulate models, the amplification characteristics are contained in digitally programmable memory; the programming port allows direct programming of the circuit and adjustment of device parameters through the interface to a personal computer and proprietary Articulate Programming Software.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Articulate G1 Series Hearing Aids:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Met all applicable specifications developed by the manufacturer.	The devices met all applicable specifications developed by the manufacturer in accordance with test methods outlined in ANSI S3.22-1996, "Specification of Hearing Aid Characteristics".
Compliance with ANSI S3.22-1996 "Specification of Hearing Aid Characteristics"	The performance characteristics were evaluated in accordance with ANSI S3.22-1996.

Study Information

Sample size used for the test set and the data provenance: Not explicitly stated. The document mentions "Performance data" was evaluated, but it does not specify the number of hearing aids tested or where the test data came from (e.g., patient trials, lab-simulated environments).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" here refers to whether the devices meet technical specifications, not a clinical diagnosis or assessment requiring expert consensus.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. The assessment is against established technical specifications (ANSI S3.22-1996), not subjective human interpretation.
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 tool. The study described is a performance/compliance test, not a comparative effectiveness study involving human readers or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, in the sense that the device's technical performance was measured directly against specifications. This is an evaluation of the device as a standalone product, not an algorithm's performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" is defined by the applicable specifications developed by the manufacturer in accordance with ANSI S3.22-1996, "Specification of Hearing Aid Characteristics". This is a technical standard/specification.
The sample size for the training set: Not applicable. This is not a machine learning or AI-driven device that requires a training set. The performance evaluation is against a fixed set of technical specifications for hardware.
How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device and study.

Summary

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K9646603

DEC - 6 1996

SECTION 2

510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.

Submitter's Name: Decibel Instruments, Inc. 3857 Breakwater Avenue Hayward, CA 94545 USA Telephone: (510) 264-4330 Contact Person: Adnan Shennib, President

Date of Summary: November 18, 1996

Device Name: Articulate™ G1 Series Hearing Aids

Legally Marketed Devices To Which Equivalence Is Claimed: The legally marketed predicate devices to which equivalence is claimed are:

The Starkey Laboratories Tympanette (K933407), determined to be substantially . equivalent to a pre-enactment device on October 7, 1993;
. The General Hearing Instruments In-the-Ear Hearing Aid (K850123), determined to be substantially equivalent to a pre-enactment device on March 21, 1985; and
. The Resound Corporation Resound ITE Hearing Enhancement System (HES) (K884871), determined to be substantially equivalent to a pre-enactment device on February 21; 1989.

Device Description: The Articulate G1 Series Hearing Aids amplify and deliver sounds via air conduction to the external ear of persons with hearing losses. The microphone transforms sound waves into electrical signals and delivers it to the hearing aid circuit, which is powered by the battery. In the non-programmable Articulate models, the potentiometers of the circuit are used by the hearing aid dispenser to manually modify the amplification characteristics of the incoming signal. In the programmable Articulate models, the amplification characteristics are contained in digitally programmable memory; the programming port allows direct programming of the circuit and adjustment of device parameters through the interface to a personal computer and proprietary Articulate Programming Software.

Decibel Instruments, Inc. . 3857 Breakwater Avenue . Hayward, CA 94545 . Tel: 510/264-4330 . Fax: 510/264-4398

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Intended Use: The Articulate G1 Series Hearing Aids are wearable, sound-amplifying devices that are intended to compensate for impaired hearing. The intended use of the Articulate series hearing aids is identical to that of the legally marketed predicate devices.

Descriptive Summary Of Technological Characteristics And Those Of Predicate Devices:

The non-programmable Articulate G1 Series models (G1-12-MM, G1-12-MS, G1-24-MM, and G1-24-MS) are air conduction hearing aids, with in-the-canal to deep canal fitting. Electronics are external to the second bend of the ear canal, with receiver located around the second bend, transmitting sound to the tympanic membrane. The potentiometers of the circuit are used to change the amplification characteristics of the incoming signal. Two volume control settings are modified by a switch on the faceplate. These characteristics are similar to the Starkey Laboratories Tympanette and to the General Hearing Instruments In-the-Ear Hearing Aid (EZ-Ear).

The programmable Articulate G1 Series models (G1-P24-MM, and G1-P24-MS) are air conduction hearing aids, with in-the-canal to deep canal fitting. Electronics are external to the second bend of the ear canal, with receiver located around the second bend, transmitting sound to the tympanic membrane. Amplification characteristics are contained in digitally programmable memory and direct programming of hearing aid circuit occurs through interface to a personal computer and and programming software. Two volume control settings are modified by a switch on the faceplate. These characteristics are similar to the General Hearing Instruments In-the-Ear Hearing Aid (EZ-Ear) and to the Resound ITE Hearing Enhancement System (HES).

Performance data: The performance characteristics of the Articulate G1 Series Hearing Aids have been evaluated in accordance with ANSI S3.22-1996, "Specification of Hearing Aid Characteristics". The devices met all applicable specifications developed by the manufacturer in accordance with test methods outlined in the specification.

Lisa S. Jones
Lisa S. Jones

Regulatory Affairs Consultant Decibel Instruments, Inc.

Nov. 15, 1996

Date

Decibel Instruments, Inc. · 3857 Breakwater Avenue · Hayward, CA 94545 · Tel: 510/264-4330 · Fax: 510/264-4398

6 3

Regulation Number and Section

§ 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.