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Additional Information
Instructions for use in the USA
Caution: Federal law (USA) restricts this device
to sale or by the order of a medical practitioner.
Warning to hearing aid dispensers
A prospective Baha user must always have
a medical evaluation by a licensed physician
(preferably an ear specialist) and have an implant
placed in the skull bone before a Baha sound
processor can be dispensed. The Baha sound
processor can be used with a Softband or a
SoundArc which does not require an implant.
However, a medical evaluation is still warranted.
Important notice for prospective users of a
Baha sound processor
• A prospective Baha user must always have
a thorough medical evaluation by a licensed
physician (preferably a physician who specializes
in diseases of the ear, otolaryngologist, otologist,
or otorhinolaryngologist) and have an implant
placed in the skull bone before a Baha sound
processor is purchased.
• The purpose of the medical evaluation is to
ensure that all medically treatable conditions
that may affect hearing are identified and
treated before the sound processor is purchased.
Following the medical evaluation, the physician
will give you a written statement that states
that your hearing loss has been medically
evaluated and that you may be considered a
Baha candidate. The physician will refer you
to an audiologist or a hearing aid dispenser, as
appropriate, for an audiological evaluation.
• Federal law restricts the sale of Baha sound
processors to those individuals who have
obtained a medical evaluation from a licensed
physician. Federal law permits a fully informed
adult to sign a waiver statement declining the
medical evaluation for religious or personal
beliefs that preclude consultation with a
physician. The exercise of such a waiver is not in
your best health interest and its use is strongly
discouraged.
A word of caution about batteries
Batteries can be harmful if swallowed. Be sure to
always keep your batteries out of reach of small
children, pets, or people of diminished capacity.
In the event a battery is accidentally swallowed,
seek prompt medical attention at the nearest
emergency center, or call the National Button
Battery Hotline collect at (202) 625 – 3333.
UKCA mark
The UKCA mark is only applicable to Baha 6 Max.
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