Section 216-RICR-40-05-31.4 - Administrative Requirements31.4.1Certificates of Need and Other Requirements Prior to Delivery of ServicesA. No person, firm, association or corporation shall sell or attempt to sell or otherwise make available any hearing aid instrument or hearing prosthetic device to a prospective consumer or purchaser unless that consumer or purchaser has first obtained and presented to the seller a certificate of need on forms prescribed and furnished by the Director, signed by a physician duly licensed in the state under the provisions of R.I. Gen. Laws Chapter 5-37, attesting thereon that pursuant to an ontological examination no more than six (6) months prior to the sale of the hearing aid, it is his/her diagnosis that the prospective patient-purchaser has a hearing impediment of such a nature as to indicate the need for a hearing aid instrument or hearing prosthetic device.B. Pursuant to federal requirements, an adult (i.e., person aged eighteen [18] years or older) prospective purchaser may waive the medical evaluation requirement provided that said purchaser has been informed that the exercise of said waiver is not in the purchaser's best interest. 1. A statement shall be signed by the prospective purchaser indicating informed consent regarding the waiver described in §31.4.1(B) of this Part. Said statement shall be retained for no less than three (3) years by the licensee in accordance with federal requirements.2. Any person engaging in the practice of fitting and dealing in hearing aids will, when dealing with a child ten (10) years of age or under, ascertain whether the child has been examined by an otolaryngologist or primary care physician and an audiologist for his/her recommendation within ninety (90) days prior to the fitting. If that not be the case, a recommendation to do so must be made and such an examination must be conducted before the sale of any hearing aid.C. Prior to delivery of services or products to the prospective purchaser, a licensee shall provide discussion of amplification or aural rehabilitation options appropriate to the hearing loss and communication needs presented by the patient.D. The licensee shall deliver information, either written or oral, appropriate to the patient's needs and options under discussion, including, but not limited to, types of circuitry, telecoils, or programmability, and if applicable, estimated unit prices for the following service: hearing aid(s), accessories, service contracts, hearing aid (loss and damage) insurance, health care coverage, warranty, financing, and related goods and services.31.4.2Records of TransactionsA. The Records of Transactions are as set forth in R.I. Gen. Laws § 5-49-2.2.B. Every person, firm, association or corporation shall keep a permanent record of all sales or other transactions whereby a hearing aid instrument or hearing prosthetic device is made available.C. Each record of a transaction shall have attached thereto the certificate of need, or signed waiver, presented by the prospective purchaser and shall be retained for a period of three (3) years and be kept open for inspection by any official designated by the Director.Receipt Requirements are in accordance with R.I. Gen. Laws § 5-49-3.
216 R.I. Code R. § 216-RICR-40-05-31.4