(18 days)
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No
The description details traditional signal processing and manual or digital programming of amplification characteristics, with no mention of AI or ML.
Yes
The device is intended to compensate for impaired hearing, which is a therapeutic purpose.
No
The device is a sound-amplifying device intended to compensate for impaired hearing, not to diagnose a condition.
No
The device description clearly outlines hardware components such as microphones, circuits, batteries, and potentiometers, indicating it is a physical hearing aid with embedded software, not a standalone software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Articulate G1 Series Hearing Aids are described as "wearable, sound-amplifying devices that are intended to compensate for impaired hearing." They work by amplifying external sounds and delivering them to the ear.
- Lack of Biological Sample Analysis: The description does not mention the device analyzing any biological samples from the patient. Its function is purely related to processing and amplifying sound waves.
Therefore, the Articulate G1 Series Hearing Aids fall under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for 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.
Product codes
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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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
external ear / ear canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hearing aid dispenser (for non-programmable models)
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
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