(34 days)
No
The device description focuses on standard hearing aid components and programmable options, with no mention of AI or ML technologies. The predicate device is also a standard programmable hearing aid from 1993.
Yes
The device is a hearing aid, which is used to compensate for hearing loss, indicating a therapeutic purpose.
No
Explanation: The device is described as a hearing aid intended to compensate for hearing loss by amplifying sound. Its function is to assist rather than diagnose a condition.
No
The device description explicitly states it is a "Custom fit air conduction hearing aid" and mentions physical components like "volume control," "switches," and "standard hearing aid batteries," indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states the device's intended use is "To assist in compensating for hearing loss by amplifying sound pressure waves as they enter the ear." This is a device that interacts with the external environment and the ear to improve hearing, not to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in the body.
- Providing diagnostic information based on laboratory tests.
The device described is a hearing aid, which is a medical device but falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
To assist in compensating for hearing loss by amplifying sound pressure waves as they enter the ear.
Product codes
Not Found
Device Description
The Starkey Custom Sequel Programmable and K-Amp Programmable are air conduction hearing aids that are designed to be all-in-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.
Available as ITE, ITC, CIC .
6 Programmable Features .
Programmed with Pro-Connect or . Hi-Pro systems and PFS software
Non Volatile Memory .
Full range programmability from . 100dB SSPL to 117dB SSPL, 20dB qain to 50dB qain
Totally programmable class D . compression instrument
Programmable with pr3000 with PFS software or PFS 6000
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hearing Health Professional
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
NOV 27 1996
SAFETY AND EFFECTIVENESS SUMMARY -Starkey Custom Sequel Programmable, K Amp Programmable
| NAME OF DEVICE: | Starkey Custom Sequel Programmable and K Amp programmable
air conduction hearing aids. |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| TYPE OF DEVICE: | Custom fit air conduction hearing aids available as ITE, ITC, or CIC
-- Substantially equivalent to the Starkey CE-9 Resolution programmable
hearing aid, (K933989) |
| INTENDED USE: | To assist in compensating for hearing loss by amplifying sound pressure
waves as they enter the ear. |
| FEATURES: | Adjustable hearing aid volume control, color coding for left and right
instruments, 6 programmable options: Low cut, High cut, Gain control,
Compression ratio, Threshold knee, and Output limiting for Sequel, or
Loudness Boost for K Amp. |
| 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 +6 dB, -4 dB
for gain. |
| CONTROLS: | Volume controls, similar to those used on other hearing aid devices.
Switches may be incorporated as options require. Any switches are similar
to those used in other hearing aid devices. |
| POWER: | Standard hearing aid batteries. |
1
SUMMARY-- STARKEY Custom Sequel Programmable and K Amp Programmable SUBSTANTIAL EQUIVALENCE
The Starkey Custom Sequel Programmable and K-Amp Programmable are air conduction hearing aids that are designed to be all-in-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 Custom Sequel Programmable and K-Amp Programmable aids are substantially equivalent to the Starkey CE-9 Resolution(K933989). The Starkey Custom Sequel Programmable and K-Amp Programmable are available as ITE, ITC, and CIC hearing aids. They are programmed by using the Pro-Connect (K932269) or Hi-Pro systems with the PFS software. The may also be programmed with the Rastronics pr3000 with the PFS software, or the PFS 6000.
CE 9 RESOLUTION
- Available as ITE ●
- 6 Programmable Features .
- Programmed with Trilogy Desktop . or Pro-Connect
- Non Volatile Memory .
- Full range programmability from t 105dB SSPL to 125dB SSPL, 30dB qain to 60dB qain
- . Class D output instrument with compression available
- Memory holds two responses which . can be switched by user
Custom Sequel, K Amp Programmable
- Available as ITE, ITC, CIC .
- 6 Programmable Features .
- Programmed with Pro-Connect or . Hi-Pro systems and PFS software
- Non Volatile Memory .
- Full range programmability from . 100dB SSPL to 117dB SSPL, 20dB qain to 50dB qain
- Totally programmable class D . compression instrument
- Programmable with pr3000 with ● PFS software or PFS 6000