← Product Code [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD) · K964244

# STARKEY CUSTOM SEQUEL PROGRAMMABLE AND K AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS (K964244)

_Starkey Laboratories, Inc. · ESD · Nov 27, 1996 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K964244

## Device Facts

- **Applicant:** Starkey Laboratories, Inc.
- **Product Code:** [ESD](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD.md)
- **Decision Date:** Nov 27, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.3300
- **Device Class:** Class 1
- **Review Panel:** Ear, Nose, Throat
- **Attributes:** Therapeutic

## Intended Use

To assist in compensating for hearing loss by amplifying sound pressure waves as they enter the ear.

## Device Story

Custom-fit air conduction hearing aids (ITE, ITC, CIC); amplify sound pressure waves for hearing loss compensation. Operated by hearing health professionals; programmed via Pro-Connect, Hi-Pro, Rastronics pr3000, or PFS 6000 systems using PFS software. Features include adjustable volume, color coding, and 6 programmable options (Low/High cut, Gain, Compression ratio, Threshold knee, Output limiting/Loudness Boost). Powered by standard hearing aid batteries. Non-volatile memory stores settings. Output adjustments based on patient-specific frequency response needs.

## Clinical Evidence

Bench testing only; compliance with ANSI S3.22-1987 standards for technical specifications.

## Technological Characteristics

Air conduction hearing aids; ITE, ITC, CIC form factors. Class D output circuitry. Programmable features: Low cut, High cut, Gain, Compression ratio, Threshold knee, Output limiting/Loudness Boost. Powered by standard batteries. Technical specs comply with ANSI S3.22-1987. Tolerances: ± 4 dB for SSPL/slope, +6/-4 dB for gain.

## Regulatory 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.

## Predicate Devices

- Starkey CE-9 Resolution programmable hearing aid ([K933989](/device/K933989.md))

## Reference Devices

- Pro-Connect ([K932269](/device/K932269.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

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K964244

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.  |

10/16/96

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# 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 105dB SSPL to 125dB SSPL, 30dB gain to 60dB gain
- 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 gain to 50dB gain
- Totally programmable class D compression instrument
- Programmable with pr3000 with PFS software or PFS 6000

10/16/96

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K964244](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K964244)

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