FDA Adverse Event Injury Summary report: N

AVANT A2D+ AUDIOMETER

MDR report key: 23621812 · Received November 21, 2025

Report

Report Number
MW5179308
Event Type
Injury
Date Received
November 21, 2025
Date of Event
February 4, 2025
Report Date
November 18, 2025
Manufacturer
MEDRX, INC.
Product Code
EWO
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
AL, US
Reporter Occupation
PATIENT
Health Professional
N

Narratives

Description of Event or Problem · 0

I GOT A FLYER IN THE MAIL FROM MY LOCAL (B)(6) OFFICE HERE IN (B)(6). IT STATED THAT THEY WERE SPONSORING A PRODUCT FIELD TEST IN MY AREA TO DETERMINE THE BENEFITS OF THEIR LATEST TECHNOLOGY. THEY WERE SEEKING 15 QUALIFIED CANDIDATES TO PARTICIPATE. THERE WERE 4 QUALIFICATIONS FOR THE FIELD TEST. (1) LIVE IN THE (B)(6) AREA. (2) ARE AT LEAST 55 YEARS OR OLDER (3) HAVE SOME LEVEL OF HEARING DIFFICULTY & (4) DON'T WORK FOR A MARKET RESEARCH COMPANY. I MET ALL FOUR, SO I SET UP AN APPOINTMENT TO SEE THEM ON (B)(6) AT 12:30PM. AT THE FIRST APPOINTMENT I WAS LED TO A SOUNDPROOF HEARING BOOTH. WE PUT ON THE EAR CABLES FROM THE TESTING MACHINE. HE SAYS I WANT YOU TO PUSH THE BUTTON WHENEVER YOU FIRST START TO HEAR A SOUND. WE DID THE RIGHT EAR FIRST. I WASN'T COUNTING BUT I THINK I HEARD 6 TO 8 SOUNDS VARYING IN FREQUENCY OR PITCH. THEN WE DID THE LEFT EAR WITH THE SAME RESULTS. THEN HE SAYS FOR THIS LAST TEST WE WILL SWITCH BACK TO THE RIGHT EAR. I DON'T KNOW THE EXACT WORDS HE USED BUT HE INDICATED THAT THERE MIGHT BE SOME SLIGHT DISCOMFORT, SO IF YOU NOTICE ANY DISCOMFORT NO MATTER HOW SLIGHT IT IS, PUSH THE BUTTON. ON THE RIGHT EAR I DID NOT HEAR ANY SOUND AT ALL, BUT I NOTICED SOMETHING, SO I PUSHED THE BUTTON. WE NOW SWITCH OVER TO MY LEFT EAR AND DO THE SAME THING, BUT THIS TIME I DIDN'T HEAR ANYTHING EITHER, BUT I NOTICED SLIGHT DISCOMFORT AND 3 OR 4 POPPING OR CRACKLING SENSATIONS, AND I PUSHED THE BUTTON. JUST AFTER THE HEARING TEST I FELT FINE, AND WE PROCEEDED WITH ORDERING THE HEARING AIDS I WAS TO USE. THIS SAME NIGHT AS OUR FIRST OFFICE VISIT ON (B)(6), I NOTICED SOMETHING WAS NOT RIGHT BUT COULD NOT SAY WHAT. ON THE FOLLOWING DAY ((B)(6) 2025) I STARTED NOTICING SOME RINGING IN MY EARS AND HAD SOME TROUBLE FALLING ASLEEP. ON (B)(6) 2025 THE RINGING IN MY EARS HAS GOTTEN VERY LOUD AND BOTHERSOME. ENOUGH THAT I COULDN'T CONCENTRATE. THIS NIGHT I ONLY GOT 3 HOURS OF SLEEP, THE RINGING IN MY EARS WOULD NOT LET ME GO TO SLEEP. ON (B)(6) 2025 ¿ THE RINGING IN MY EARS IS NONSTOP AND LOUD, AND I'M REALIZING SOMETHING IS VERY WRONG. KNOWING WHAT TINNITUS IS, I'M DOING RESEARCH ON THIS MATTER. I WAS ALSO NOT FEELING VERY WELL AND THOUGHT I MIGHT BETTER CHECK MY BLOOD PRESSURE. AT NOON IT WAS 163/77 WHICH IS HIGH FOR ME. I CHECKED IT AGAIN AT NIGHT BEFORE BED AND IT WAS 170/74. I GOT ONLY 3 OR 4 HOURS OF SLEEP TONIGHT. I WOKE UP AT 4:00AM, I THINK BECAUSE OF THE RINGING IN MY EARS. I TOOK MY BLOOD PRESSURE, AND IT WAS VERY HIGH 182/79. I CALLED DR. (B)(6) OFFICE TO MAKE AN APPOINTMENT TO SEE HIM, BUT THE MESSAGE SAID THEY WERE CLOSED ON FRIDAYS. I WAS ABLE TO GET IN AND SEE HIM ON MONDAY (B)(6), AT 1:30PM. HE ACKNOWLEDGED THAT I HAD TINNITUS, BUT HIS REPORT SAID IT WAS BILATERAL WHICH WAS WRONG. IT IS ONLY IN MY LEFT EAR. HE ALSO SAID I COULDN'T USE BP MEDICINE AS NEEDED. HE STATED THAT 190/110 IS THE DANGER ZONE FOR HIGH BP. I FOUND OUT THAT THE AUDIOMETER THAT MY MIRACLE EAR LOCATION HERE IN (B)(6) WAS USING IS THE AVANT A2D+ AUDIOMETER FOR HEARING TESTING. FURTHER RESEARCH INTO THIS DEVICE SHOWS THAT IT CAN REACH 120 DECIBELS IN VOLUME. ENOUGH TO DAMAGE YOUR EARS. 3,800 CHARACTERS IS TOO SHORT TO FULLY DESCRIBE MY CASE. I HAD BEEN TAKING NOTES ON MY ENCOUNTER WITH (B)(6) OFFICE BECAUSE I THOUGHT THEY WANTED TO KNOW HOW THE HEARING AIDS WERE PERFORMING. THIS WAS A 3-WEEK TRIAL, SO THIS ENCOUNTER IS FULLY DOCUMENTED. IF YOU NEED MORE INFORMATION ON THIS CASE, PLEASE CONTACT ME AT (B)(6) OR BY CELLPHONE (B)(6) OR BY MAIL AT (B)(6). I HAVE THE AUDIOGRAM FROM MY HEARING TEST WHICH DOES SHOW THAT I HAVE SEVERE HEARING LOSS AT THE 6,000 HZ RANGE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2578040 AVANT A2D+ AUDIOMETER AUDIOMETER EWO MEDRX, INC.

Patients

Seq Age Sex Outcome Treatment
1 76 YR Male Disability