(36 days)
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No
The summary describes a standard hearing aid with no mention of AI or ML capabilities, training data, or performance metrics typically associated with such technologies.
Yes
The device is described as a hearing aid intended to compensate for hearing loss by amplifying sound, which aligns with the definition of a therapeutic device.
No
The device is described as a hearing aid intended to compensate for hearing loss by amplifying sound, which is a therapeutic function, not a diagnostic one. It doesn't mention any capability to diagnose conditions or diseases.
No
The device description explicitly states it is a "behind-the-ear hearing aid," which is a hardware device.
No, 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 provided description clearly states the device's intended use is to "assist in compensating for hearing loss by amplifying sound as it comes into the ear." This is a therapeutic function, not a diagnostic one performed on a biological sample.
- Lack of IVD Indicators: The description does not mention any of the typical characteristics of an IVD, such as analyzing biological samples, detecting biomarkers, or providing diagnostic information.
Therefore, based on the provided information, the Starkey A-13 air conduction hearing aid is a medical device for hearing assistance, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
To assist in compensating for hearing loss by amplifying sound as it comes into the ear.
Product codes
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Device Description
The Starkey A-13 air conduction hearing aids are designed to be behind-the-ear hearing aids. This form of hearing aid is intended to be received by a Hearing Health Professional in a completed form, not being intended for final assembly.
Adjustable hearing aid volume controls, six programmable trimmer options, and telephone switch. Assembled from standard components that are widely used in hearing aid devices throughout the industry. Technical specifications comply with ANSI S3.22-1987. Frequency response varying based on the needs of the patient. Tolerances are maintained to a ±4 dB range for SSPL. and slope, with ±4dB for gain. For conductive and/or sensori-neural hearing loss where BTE type hearing aids are preferred or required. Volume controls, similar to those used on other hearing aid devices. Pots or switches are similar to those used in other hearing aid devices.
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
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Indicated Patient Age Range
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Intended User / Care Setting
Hearing Health Professional
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)
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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
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§ 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
Nov 26 1996
SUMMARY-- STARKEY A-13 PROGRAMMABLES SUBSTANTIAL EQUIVALENCE
The Starkey A-13 air conduction hearing aids are designed to be behind-the-ear hearing aids. This form of hearing aid is intended to be received by a Hearing Health Professional in a completed form, not being intended for final assembly.
The Starkey A-13s are substantially equivalent to the BOSH Star 42 hearing aid (K942594). Variable high and low frequency cut potentiometers can be set by a Dispenser to tune to more specific frequencies. All other aspects of these A-13s are similar to the BOSH Star 42 hearing aid.
Starkey A-13 Programmable Sequel / K-AMP
- BTE air conduction ●
- Adiustable Gain Control ●
- Six program features ●
- Programmable using the . Professional Fitting System software and Pro-connect or High-Pro Systems.
- Programmable using the PR 3000 . or PFS 6000 with PFS software
- . Fits mild to moderate hearing losses
- Audio input capabilities ●
- Telephone/Mic/Off Switch ●
- 13 or equiv. battery ●
Bosh Star 42 Digitally Programmable
- BTE air conduction .
- Adjustable Gain Control .
- Telephone/Mic/Off Switch .
- Digitally programmable using the . Starkey Trilogy desktop programmer or the Pro-connect system
- 10 programmable features .
- Fits moderate to profound hearing . losses
- Audio input capabilities ●
- 675 or equiv. battery .
- Colors: Exchangeable casings . available in various colors
10/16/96
1
SAFETY AND EFFECTIVENESS SUMMARY - STARKEY A-13 PROGRAMMABLE HEARING AIDS
| NAME OF DEVICE: | Starkey A-13 Sequel programmable, A-13 K-AMP
programmable air conduction hearing aids. |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| TYPE OF DEVICE: | Standard BTE air conduction hearing aids -- Substantially
equivalent to the Bosh Star 42 hearing aid, (K942594) |
| INTENDED USE: | To assist in compensating for hearing loss by amplifying
sound as it comes into the ear. |
| FEATURES: | Adjustable hearing aid volume controls, six programmable
trimmer options, and telephone switch. |
| ASSEMBLY: | Assembled from standard components that are
widely used in hearing aid devices throughout the
industry. |
| TECHNICAL
CHARACTERISTICS: | Technical specifications comply with ANSI
S3.22-1987 |
| FIT: | Frequency response varying based on the needs of
the patient. Tolerances are maintained to a ±4 dB
range for SSPL. and slope, with ±4dB for gain. For
conductive and/or sensori-neural hearing loss where
BTE type hearing aids are preferred or required. |
| CONTROLS: | Volume controls, similar to those used on other
hearing aid devices. Pots or switches are similar to those
used in other hearing aid devices. |
| | |
10/16/96