CHAPTER 123
PRACTICE OF HEARING AID DISPENSING
645—123.1(154A) Definitions. For the purposes of these rules, the following definitions apply:
“Health history” means a series of questions pertaining to all of the following: client hearing needs and expectations; communication issues; otological conditions; medications; and previous amplification.
“Hearing aid fitting” means any of the following: the measurement of human hearing by any means for the purpose of selections, adaptations, and sales of hearing aids, and the instruction and counseling pertaining thereto, and demonstration of techniques in the use of hearing aids, and the making of earmold impressions as part of the fitting of hearing aids.
“Sales receipt” means a written record that is provided to a person who purchases a hearing aid, that complies with theses rules, and that is signed by the purchaser and the licensed hearing aid dispenser. The requirements for the sales receipt may be found in rule 645—123.3(154A).
[ARC 9424B, IAB 3/9/11, effective 4/13/11]
645—123.2(154A) Requirements prior to sale of a hearing aid.
	123.2(1) No hearing aid shall be sold to an individual 18 years of age or older unless the individual:
	a. 	Provides a health history to a licensed hearing aid dispenser who is responsible for reducing the history to written form;
	b. 	Presents a physician statement verifying that a medical evaluation, preferably by a physician specializing in diseases of the ear, has been done within the previous six months and stating the individual’s hearing loss and that the individual may benefit from a hearing aid. In lieu of this requirement, the individual may verify in writing that the individual has been informed that it is in the individual’s best health interests to obtain a medical evaluation by a licensed physician specializing in diseases of the ear, or if no such licensed physician is available in the community, then a duly licensed physician, and that the individual chooses to waive said evaluation; and
	c. 	Is given a hearing examination that utilizes appropriate established procedures and instrumentation for the measurement of hearing and the fitting of hearing aids and that includes, but is not limited to, an assessment of the following: air conduction; bone conduction; masking capability; speech reception thresholds; speech discrimination; uncomfortable loudness levels (UCL) and most comfortable levels (MCL). An examination that includes these procedures within the past 12 months shall be an exception to this requirement if the procedures and results are documented in the client record.
	123.2(2) Whenever any of the following conditions are found to exist either from observations by the licensed hearing aid dispenser or person holding a temporary permit or on the basis of information furnished by a prospective hearing aid user, the hearing aid dispenser or person holding a temporary permit shall, prior to fitting and selling a hearing aid to any individual, suggest to that individual in writing that the individual’s best interests would be served if the individual would consult a licensed physician specializing in diseases of the ear, or if no such licensed physician is available in the community, then a duly licensed physician:
	a. 	Visible congenital or traumatic deformity of the ear.
	b. 	History of, or active drainage from the ear within the previous 90 days.
	c. 	History of sudden or rapidly progressive hearing loss within the previous 90 days.
	d. 	Acute or chronic dizziness.
	e. 	Unilateral hearing loss of sudden or recent onset within the previous 90 days.
	f. 	Significant air-bone gap (greater than or equal to 15dB ANSI 500, 1000 and 2000 Hz. average).
	g. 	Obstruction of the ear canal, by structures of undetermined origin, such as foreign bodies, impacted cerumen, redness, swelling, or tenderness from localized infections of the otherwise normal ear canal.
	123.2(3) Testing shall not be required in cases in which replacement hearing aids of the same make or model are sold within one year of the original sale.
	123.2(4) Except as otherwise provided in these rules, for individuals younger than 18 years of age, all of the requirements stated in these rules are applicable. In addition, the following are required:
	a. 	Written authorization of a parent or legal guardian consenting to the services covered in these rules, and
	b. 	An original signature on all documents required by law or these rules to be signed, including but not limited to, all sales transactions and receipts, required notifications, and warranty agreements.
	123.2(5) For individuals 12 years of age or younger, all of the requirements stated in these rules are applicable. In addition, the parent or legal guardian must first present a written, signed recommendation for a hearing aid from a licensed physician specializing in otolaryngology. The recommendation must have been made within the preceding six months. A replacement of an identical hearing aid within one year shall be an exception to this requirement.
[ARC 9424B, IAB 3/9/11, effective 4/13/11]
645—123.3(154A) Requirements for sales receipt. Upon sale of a hearing aid device, the licensee shall provide to the person a sales receipt, which shall include the following:
	1.	Licensee’s signature.
	2.	Licensee’s business address.
	3.	Licensee’s license number.
	4.	Client signature and address.
	5.	Make, model, and serial number of the hearing aid furnished.
	6.	Statement to the effect that the aid or aids delivered to the purchaser are used or reconditioned, if that is the fact.
	7.	Full terms of sale, including:
	●	The date of sale;
	●	Specific warranty terms, including whether any extended warranty is available through the manufacturer;
	●	Specific return policy; and
	●	Whether any trial period is available.
	8.	The following statement in type no smaller than the largest used in the body copy portion of the receipt: “The purchaser has been advised that any examination or representation made by a licensed hearing aid dispenser in connection with the fitting or selection and selling of this hearing aid is not an examination, diagnosis, or prescription by a person licensed to practice medicine in this state and therefore, must not be regarded as medical opinion or advice.”
[ARC 9424B, IAB 3/9/11, effective 4/13/11]
645—123.4(154A) Requirements for record keeping. A licensee shall keep and maintain records in the licensee’s office or place of business for a seven-year period.
	123.4(1) The records for each person shall include:
	a. 	A complete record of each test performed and the results of the test.
	b. 	A copy of any written recommendations.
	c. 	A copy of medical clearances or waivers.
	d. 	A copy of the written sales receipt.
	e. 	A copy of terms of sale, including any warranty.
	f. 	A written record of any adjustments or services provided on the hearing aid device, including whether such services were provided under warranty or other agreement.
	123.4(2) No less than 30 days prior to closure of a licensee’s business, the licensee shall provide written notification to clients of the location at which records will be maintained for a period of no less than 30 days following closure and the procedure to obtain those records. The licensee may arrange the transfer of records to another licensee for the purpose of maintenance of the records, provided that all contractual agreements have been satisfied.
[ARC 9424B, IAB 3/9/11, effective 4/13/11]
These rules are intended to implement Iowa Code chapter 154A.
[Filed ARC 9424B (Notice ARC 9317B, IAB 12/29/10), IAB 3/9/11, effective 4/13/11]