- 6.01 Minimal procedures and equipment
- 6.02 Certification of test equipment
- 6.03 Medical clearance requirements/clients under 18 years of age
- 6.04 Cancellation of sale
- 6.05 Bill of sale requirements
- 6.06 Sale of hearing instruments by mail
- 6.07 Updated licensure information/notification of employment
- 6.08 Facility and record inspection requirements
6.01 Minimal Procedures and Equipment
(1) The following minimum procedures shall be used in the fitting and selling of hearing instruments:
(a) pure tone audiometric testing by air and bone conduction pathways through a calibrated system in the appropriate environment to determine the type and degree of hearing deficiency;
(b) effective masking when indicated;
(c) appropriate testing using a calibrated system or other acceptable verification technique in the appropriate environment to determine client's hearing ability, as measured by the percentage words the client is able to repeat correctly, the client's ability to discriminate speech, the client's most comfortable and uncomfortable loudness levels in decibels, and the best fitting arrangement for maximum hearing aid benefit;
(d) otoscopic inspection of the outer ear;
(e) a pertinent case history; and
(f) a final fitting ensuring physical and operational comfort of the hearing aid.
(2) Mandatory disclosure. Any person with a 15 dB or greater difference between air conduction and bone conduction hearing, at three frequencies of 500 hz, 1000hz, and 2000hz in either ear, must be advised of the possibility of medical correction.
(3) At a minimum, the following required equipment shall be used:
(a) a wide-range audiometer which meets the specifications of the American National Standards Institute for diagnostic audiometers;
(b) a speech audiometer or a master hearing aid in order to determine the most comfortable listening level and speech discrimination.
6.02 Certification of Test Equipment
(1) Each audiometric test conducted by a registrant or apprentice in the fitting or selling of hearing aids must be conducted on equipment that has been calibrated on at least an annual basis.
(2) It is the responsibility of a registrant to maintain records proving that all test equipment is properly calibrated on at least an annual basis.
(3) Upon request, a registrant shall furnish to Division or Board copies of documentation certifying proper calibration of test equipment used.
6.03 Medical Clearance Requirements/Clients Under 18 Years of Age
(1) Medical clearance. If, upon inspection of the ear canal with an otoscope in the common procedure of a hearing aid fitting and upon questioning of the client, there is recent history of infection, any observable anomaly, deformity of ear, unilateral loss of hearing within 90 days, bilateral loss of hearing within ninety (90) days, evidence of cerumen or other occlusion, pain in the ear, discharge, ear bone gap at 15 Db at 500 hz, 1000 hz, and 2000 hz or dizziness, the client shall be instructed to see a physician. A hearing aid shall not be fitted until medical clearance is obtained for the condition noted or a waiver of informed consent is signed by the client. If, upon the client's return, the condition noted is no longer observable and the client signs a medical waiver, a hearing aid may be fitted.
(2) Clients under 18 years of age. A registrant or apprentice shall not sell a hearing instrument to a person under eighteen (18) years of age unless the client, a parent, or guardian has presented to the registrant or apprentice a written statement signed by a licensed physician specializing in diseases of the ear that states that the patient's hearing loss has been medically evaluated and the patient may be considered a candidate for a hearing instrument. The physician's evaluation must have taken place within the preceding six months.
6.04 Cancellation of Sale
(1) 30-day trial period.
(a) In addition to any other rights and remedies a purchaser of a hearing instrument in Massachusetts is afforded, such purchaser shall have a 30-day trial period after date of receipt of the hearing instrument during which time such purchaser shall be entitled to a limited money back guarantee.
(b) During the 30-day period after receiving the hearing instrument, the purchaser shall be able to cancel the purchase by returning the hearing instrument or sending to the seller by certified mail a written notice of cancellation. If written notice is sent, the purchaser must return the hearing instrument to the seller within ten (10) days of the written notice being sent in order for the money back guarantee to apply.
(c) If the hearing instrument must be repaired, remade, or adjusted during the 30-day trial period, the running of the 30-day trial period is suspended one day for each 24-hour period that the hearing aid is not in the purchaser's possession. For purposes of the computation of the trial period, a repaired, remade or adjusted hearing aid must be reclaimed by the purchaser within three working days after notification of availability. The running of the 30-day trial period resumes on the day the purchaser reclaims the repaired, remade or adjusted hearing aid or on the fourth day after availability.
(2) If a purchaser cancels or rescinds a sale within the terms of this subsection, the seller shall be entitled to retain the charges for ear molds; service provided to fit the hearing aid; and any repair, remake or adjustment performed that is not contained within any other warranty of sale or service, not to exceed 20% of the purchase charge. Any charges retained shall be explained in writing to the purchaser.
(3) Regarding refunds, if a purchased hearing instrument has been damaged, the seller may deduct from any refund due the purchaser the reasonable costs incurred in repairing the hearing instrument to make it suitable for resale. If the hearing instrument has been damaged beyond repair, the purchaser is liable for the full purchase price.
6.05 Bill of Sale Requirements.
(1) A registrant shall provide to each person to whom he or she sells or leases a hearing instrument a bill of sale that shall at a minimum contain the following information:
(a) the registrant's hearing instrument specialist license number;
(b) the name of the registrant or the registrant's current business name as listed with the Secretary of State;
(c) the current business telephone number and address of the registrant;
(d) the brand, model, manufacturer or manufacturer's identification code, and serial number of the hearing instrument furnished at point of delivery;
(e) the terms of the sale, including an itemization of the total purchase price, including but not limited to the cost of the hearing aid, the ear mold, any batteries or other accessories, and any service costs;
(f) an itemization of the total purchase price including, but not limited to the cost of the hearing instrument, ear mold, batteries and other accessories, and any services provided,
(g) a statement notifying the purchaser of the limited money back guarantees as set forth in 265 CMR 6.04 and a clear and precise statement of any guarantee or trial period;
(h) the name, address and signature of the purchaser ;
(i) the date of consummation of the sale;
(j) a statement whether the hearing aid is new, used or reconditioned; and
(k) the waiver required by the provisions of MGL c. 93, §74.
(2) The registrant/seller shall provide the purchaser of a hearing instrument with any applicable manufacturer's instructional brochure that contains operating instructions, purchase privileges including manufacturer's warranty at the point of delivery.
(3) Sale of used/reconditioned hearing instruments. Before the sale of any used hearing instrument, in addition to all other requirements of this section, the registrant/seller shall inform a prospective purchaser that an instrument is "used" or "reconditioned" and shall clearly mark the bill of sale and container for such hearing instrument as "used" or "reconditioned," whichever is applicable, and provide it with the terms of a guarantee that the dealer provides.
6.06 Delivery of Hearing Instruments by Mail
No hearing instrument shall be delivered to a consumer in Massachusetts through the mail unless the consumer has had a hearing evaluation performed and an ear impression taken by a Massachusetts registrant and the consumer has signed a federally approved medical clearance waiver.
6.07 Updated licensure information/Notification of Employment
(1) Personal information. It is the responsibility of every individual registrant to notify the Board of any errors or changes in personal information displayed on his or her certificate of licensure or maintained on record by the Board including, but not limited to, name and address. Any change of information must be sent to the Board in writing within 30 days of such change.
6.08 Facility and Record Inspection Requirements
(1) Display of license. Each licensed hearing instrument specialist shall conspicuously display a current and accurate certificate of Board license in his or her place of business. Original and duplicate certificates shall be issued by the Board for a reasonable fee to a registrant operating or working in more than one location. Upon request , the registrant shall present his or her license to a customer when dispensing hearing instruments outside of his or her place of business.
(2) Record keeping requirement.
(a) Each registrant shall keep records of all services rendered and of all equipment testing and maintenance for a minimum of four (4) years. These records shall contain the names and addresses of all persons to whom services were rendered; the date the hearing instrument warranty expires; a description of the services and the dates the services were provided; and copies of any contracts, bills of sale and receipts.
(b) All records as required by this section shall be owned by the establishment or facility and shall remain with the establishment or facility in the event the registrant changes employment. If a contract between the establishment or facility and a registrant provides that the records are to remain with the registrant, copies of such records shall be provided to the establishment or facility.
(3) Right of Inspection. Any duly authorized agent or employee of the Division of Professional Licensure shall have the right to make such inspections and investigations as are necessary in order to determine the state of compliance with the provisions of M.G.L. chapter 13 sections 93 -95, M.G.L. c. 112 §§ 196 - 200 and 265 CMR 1.00 through 9.00. Such duly authorized agent or employee of the Division may enter the premises of a licensee during business hours and inspect the records of same upon a reasonable belief that a violation of applicable laws or regulations is being or has been committed or the registrant has failed or is failing to comply with provisions of the applicable laws, regulations and rules governing hearing instrument specialists.
M.G.L. c. 93, §§72-75, c. 112, §199.