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MED-EL - Implant Experience - August 2023

FDA Issues Final Rule Requiring the Use of ANSI S3.22-1996

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Today the FDA issued the final rule requiring the use of ANSI S3.22-1996 for labeling of hearing. We received notice from HIA that unless there is significant adverse comment, the final rule will go into effect on March 17, 2000. This change has been a long time coming since the standard was published in 1996 and it has not been possible to even buy the '87 standard for some time.

Frye Electronics is prepared for the changeover with the automatic test sequence that we introduced for the FONIX 6500-CX some time ago. A significant number of units have been upgraded and many new units have been ordered with this program. It is possible to keep the older 1987 sequence on the units, if desired, while adding the new one. Please send us the serial number of the unit that you would like upgraded and we will give you a quotation.

FP40:
We recently released software version 3.5 for the FP40 that provides a digital speech program for testing aids like the Senso and Prisma. For this program it is necessary to have the composite option since the real time signal is randomly interrupted to create the test. Version 3.5 also contains improvements to the DSL program that the University of Western Ontario requested. These improvements are available even without the composite option.

Special Offer:
The cost of the new Digital Speech Option is $500 and includes the DSL improvments. Version 3.5, without the digital speech, is $250. The ANSI '96 will be $500 when it is released. (WE anticipate that it will be released in the first quarter of the new year - century - millenium). However, If you want to pay for it ahead of time and place your order before the end of the year, you will get all the improvements for $750, provided you already have the Composite Option. Early units may require new boards. Send us your serial number for a formal quotation.

Contact sales@frye.com or me specifically at sfrye@frye.com Sallie Frye, Marketing Manager Frye Electronics, Inc. Email: Sallie Frye Voice: 503-620-2722 Fax: 503-639-0128

Rexton Reach - April 2024

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