Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 266 - Hearing Aid Dealers and Fitters Regulations › Subchapter 1 - General Provisions › Section 310:266-1-2 - Definitions

Current through Vol. 41, No. 20, July 1, 2024
The following words or terms, when used in this Chapter,
				  shall have the following meaning, unless the context clearly indicates
				  otherwise:
"Act"
means those statutes relating to Hearing
				  Aid Dealers and Fitters codified at 63 O.S. §§ 1-1750 through 1-1754
				  and 15 O.S. § 764.1.
"Air-conduction hearing aid"
means
a
				  hearing aid that conducts sound to the ear through the air.
[Title
				  21 CFR Part 800, §
										800.30]
"Commissioner"
means the State Commissioner of
				  Health or his/her authorized representative.
"Department"
means the Oklahoma State Department
				  of Health.
"Direct on-site supervision"
means a licensed
				  hearing aid dealer and fitter shall accompany a temporary permit holder anytime
				  the permit holder is performing the practice of fitting and dealing in hearing
				  aids.
"Hearing aid"
means any wearable instrument or
				  device designed for or offered for the purpose of aiding or compensating for
				  impaired human hearing. It includes both air conduction and bone conduction
				  devices.
"Hearing aid provider"
means
a hearing
				  aid dealer or fitter licensed pursuant to Section
				  1-1750 et seq. of Title
				  63
of the Oklahoma Statutes. [Title 15 O.S. § 764.1]
"Hearing Screening"
means a binary pure tone
				  screening at a preset intensity level for the purpose of determining if an
				  individual screened needs further testing prior to the selection or sale of a
				  hearing aid.
"Indirect supervision"
means that the
				  supervising licensed hearing aid dealer and fitter is not required to be
				  present in the same facility as is the person being supervised, but is
				  available for voice to voice contact by telephone, radio, or other means at the
				  initiation of the person being supervised. It means specific supervisory
				  activities, other than direct supervision, that are performed by a licensed
				  hearing aid dealer and fitter and that may include consultation, record review,
				  consulting, and evaluation of audiotaped or videotaped sessions, at a minimum
				  on a weekly basis.
"Involvement of a licensed person"
means
the supervision, prescription, or other order, involvement, or
				  intervention of a licensed person.
[Title
				  21 CFR Part 800, §
										800.30]
"License"
means a license issued by the
				  Commissioner to hearing aid dealers and fitters.
"Over-the-counter hearing aid"
means
an
				  air-conduction hearing aid that does not require implantation or other surgical
				  intervention, and is intended for use by a person age 18 or older to compensate
				  for perceived mild to moderate hearing impairment. The device, through tools,
				  tests, or software, allows the user to control the hearing aid and customize it
				  to the user's needs. The device may use wireless technology or may include
				  tests for self-assessment of hearing loss. The device is available
				  over-the-counter, without the supervision, prescription, or other order,
				  involvement, or intervention of a licensed person, to consumers through
				  in-person transactions, by mail, or online, provided that the device satisfies
				  the requirements
in Title
				  21 CFR Part 800, §
										800.30(b).
"Poses a reasonable threat"
means
the
				  nature of criminal conduct for which the person was convicted involved an act
				  or threat of harm against another and has a bearing on the fitness or ability
				  to serve the public or work with others in the occupation.
[63 O.S.
				  Section 1-1454(E)(2)]
"Practice of fitting and dealing in hearing
				  aids"
means those practices used for the purpose of selection,
				  adaptation and sale of hearing aids including direct observation of the ear
				  together with the counseling and instruction pertaining thereto, the testing of
				  human hearing for these purposes and the making of impressions for
				  earmolds.
"Rescission period"
means
thirty (30)
				  calendar days from the day the hearing aid is placed in the possession of the
				  purchaser.
[15 O.S. §
									764.1 (A) (3)]
"Sell"
or
"sale"
means any transfer
				  of title or of the right to use by lease, bailment, or any other contract,
				  excluding wholesale transactions with distributors or dealers.
"Sponsor"
means a person who is licensed and in
				  good standing pursuant to this Chapter to fit and dispense hearing aids and who
				  agrees to train and supervise a temporary permit holder.
"Substantially relates"
means
the nature
				  of criminal conduct for which the person was convicted has a direct bearing on
				  the fitness of ability to perform one or more of the duties or responsibilities
				  necessarily related to the occupation.
[63 O.S. 1-1454 (E)(1)]
"Temporary permit"
means a permit issued while
				  the applicant is training to become a licensed hearing aid dealer or
				  fitter.