<?xml version='1.0' encoding='UTF-8'?><device xmlns='http://www.fda.gov/cdrh/gudid' xmlns:xsi='http://www.w3.org/2001/XMLSchema-instance'><publicDeviceRecordKey>afa78752-23c5-4e2c-8c69-3866db69b161</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>4</publicVersionNumber><publicVersionDate>2023-11-17</publicVersionDate><devicePublishDate>2016-08-22</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>FONIXFP35</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>HIBCC</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>Fonix</brandName><versionModelNumber>FP35</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>058131475</dunsNumber><companyName>FRYE ELECTRONICS, INC.</companyName><deviceCount>1</deviceCount><deviceDescription>The FONIX FP35 provides quick, accurate information about how well a hearing aid works. It uses a graphical display or numerical table to show how much amplification the aid provides, which frequencies it amplifies, and how much distortion is creates. The FP35 analyzer is meant to be used primarily by hearing health professionals who fit hearing aids on hearing-impaired adults and children throughout the world. </deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>false</lotBatch><serialNumber>true</serialNumber><manufacturingDate>true</manufacturingDate><expirationDate>false</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>false</rx><otc>false</otc><contacts><customerContact><phone>5036202722</phone><phoneExtension xsi:nil="true"/><email>sales@frye.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>41184</gmdnCode><gmdnPTName>Tone audiometer, manual</gmdnPTName><gmdnPTDefinition>An electroacoustic device designed to measure the hearing threshold of a patient by presenting tones of increasing or decreasing intensity through headphones to establish the level at which the patient first becomes aware of the sounds. Changes in tone intensity, frequency, and the recording of patient responses are all performed manually.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Obsolete</gmdnCodeStatus></gmdn><gmdn><gmdnCode>41217</gmdnCode><gmdnPTName>Hearing aid tester, electrical</gmdnPTName><gmdnPTDefinition>An assembly of electronic reference devices intended to be used by a healthcare provider in a clinical setting to verify the performance of and/or calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid or group auditory trainer. The device typically consists of an acoustic complex of known cavity volume, a sound level meter, microphone, oscillators, frequency counters, microphone amplifiers, distortion analyser, chart recorder, and a hearing aid test box; some types may include a probe microphone used for real-ear measurement (REM). It does not measure hearing acuity [i.e., it is not an audiometer].</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>EWO</productCode><productCodeName>Audiometer</productCodeName></fdaProductCode><fdaProductCode><productCode>ETW</productCode><productCodeName>Calibrator, Hearing Aid / Earphone And Analysis Systems</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>