MODEL WMR BTE HEARING INSTRUMENT (MODEL WMR)

{0} NOV 26 1996 K963745 # 510(k) SUMMARY ## HEARING INNOVATIONS INCORPORATED ## MODEL WMR ## BEHIND-THE-EAR (BTE) ## HEARING INSTRUMENT Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared Robert S. Green, President Hearing Innovations Incorporated 3567 East Sunrise Drive Suite #101 Tucson, Arizona 85718 Contact Person(s): Same as above Date Prepared: September 16, 1996 Name of Device and Name/Address of Sponsor Model WMR Behind-The-Ear (BTE) Hearing Instrument Hearing Innovations Incorporated 3567 East Sunrise Drive Suite #101 Tucson, Arizona 85718 ## Classification Name The model WMR Behind-The-Ear (BTE) Hearing Instrument is among those devices commonly referred to as air conduction hearing aids. These devices have been classified by the Ear, Nose and Throat Classification Panel as Class I devices set forth in 21 CFR 874.3300 ## Action Taken to Comply With Performance Standards Performance data for this submission has been obtained in accordance with the test procedures of the American National Standard Specification of Hearing Aid Characteristics, ANSI S3.22-1987 (Revision of S3.22-1982). 1 {1} 2 # Intended Use Intended to be used as a wearable sound amplifying device to compensate for mild to severe hearing loss. # Product Description The Model WMR BTE is a dual-channel, wide-dynamic range input compression instrument which allows for loudness correction by changing compression ratios within the two bands. The WMR separates incoming signals into high and low frequency bands which can be independently compressed prior to recombination and amplification. The electronics for the hearing instrument are contained in a custom plastic case. The Model WMR BTE features three adjustable trimmers that can only be adjusted by the dispenser to meet individual patient requirements. The user may adjust the gain (loudness) of the hearing instrument by rotating the volume control dial to his/her most comfortable listening level. This hearing instrument does not require a special fitting system; however, the trimmer controls may only be adjusted by an authorized hearing aid dispenser, NOT by the consumer. Notes to this effect are included in the User Instruction Booklet included in this submission. 1) The crossover frequency between the low band and high band channels; 2) High band compression ratio; 3) Low band compression ratio # Predicate Devices The Model WMR BTE Hearing Instrument is substantially equivalent to the following successfully reviewed devices: ReSound Personal Hearing System-BT2 K943788 3M 8260 Programmable Instruments K935095 3M 8200 P Multipro BTE K953543 Siemens Full Dynamic Range Compression BTE K951828 {2} 3 # Technological Characteristics and Substantial Equivalence Like its predicate devices, the Model WMR is a behind-the-ear (BTE) air conduction hearing aid which utilizes a standard hearing aid microphone and transduces sound into an electrical signal. The signal is processed, amplified and converted back to sound by a standard hearing aid receiver. The technological characteristics available in the Model WMR BTE are similar to those in the predicate devices. Like the ReSound Personal Hearing System-BT2 predicate, the Model WMR BTE offers wide dynamic range compression; the Model WMR BTE offers two bands of compression. The 3M predicates offer a two channel programmable AGC aid with flexibility to change the crossover frequency like the Model WMR. While the predicate devices utilize digital control of an analog signal, the Model WMR BTE is adjusted by the dispenser using the three available trimmers: the crossover frequency between the low band and high band channels; high band compression ratio; low band compression ratio. No special fitting system is required to program the device. There are no technological differences between the Model WMR BTE and its predicate devices to raise any new issues of safety or efficacy.