Statement; Intended Use - ReSound ENYA User Manual

Hearing instrument type designations for models included in this user guide are: BE70, FCC ID: X26BE70,
IC: 6941C-BE70; LO85, FCC ID: X26LO85, IC: 6941C-LO85, LO90, FCC ID: X26LO90, IC: 6941C-LO90.
M70-80e FCC ID: X26M70-80e, IC: 6941C-M7080e, M60 FCC ID X26M60, IC: 6941C-M60. Please see
page 10 for a list of models referring to these types.

Statement

This device complies with part 15 of the FCC rules and ICES-003 of the IC rules.
Operation is subject to the following two conditions: (1) this device may not cause harmful inter ference,
and (2) this device must accept any interference received, including interference that may cause undesired
operation.
Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pur-
suant to part 15 of the FCC rules and ICES-003 of the IC rules. These limits are designed to provide reason-
able protection against harmful interference in a residential installation. This equipment generates, uses and
can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may
cause harmful interference to radio communications. However, there is no guarantee that interference will
not occur in a particular installation. If this equipment does cause harmful interference to radio or television
reception, which can be determined by turning the equipment off and on, the user is encouraged to try to
correct the interference by one or more of the following measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit different from the one in which the receiver is con-
nected.
• Consult the dealer or an experienced radio/TV technician for help.
Changes or modifications can void the user´s authority to operate the equipment.
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Intended use

Generic air-conduction hearing instruments are wearable sound-amplifying devices intended to compen-
sate for impaired hearing. The fundamental operating principle of hearing instruments is to receive, amplify,
and transfer sound to the ear drum of a hearing impaired person.
The products are in compliance with the following regulatory requirements:
• In EU: the device conforms to the Essential Requirements according to Annex I of Council Directive
93/42/EEC for medical devices (MDD) and essential requirements and other relevant provisions of Direc-
tive 1999/5/EC (R&TTE).
• The declaration of conformity may be consulted at www.resound.com
• In US: FCC CFR 47 Part 15, subpart C.
• Other identified applicable international regulatory requirements in countries outside the EU and US.
Please refer to local country requirements for these areas.
• Canada: these hearing instruments are certified under the rules of IC.
• Japanese Radio Law and Japanese Telecommunications Business Law Compliance. This device is grant-
ed pursuant to the Japanese Radio Law (電波法) and the Japanese telecommunications Business Law
(電気通信事業法) This device should not be modified (otherwise the granted designation number will
become invalid)
• Patents
US 7,593,537 US 8,00,849
ReSound is a registred trade mark of GN ReSound A/S
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