MAUDE Adverse Event Report: EXERCORE LLC. EUSTACHI EUSTACHIAN TUBE EXERCISER; DEVICE, INFLATION, MIDDLE EAR

Lot Number 18058-21

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tinnitus (2103); Partial Hearing Loss (4472)

Event Date 07/13/2021

Event Type  Injury  

Event Description

After visiting an urgent care practice in (b)(6) due to the sensation of ear fullness and being told that i had "fluid in my ears", i bought a eustachi at my local (b)(6) to rectify the problem.I used the eustachi, as directed, occasionally in (b)(6) and early (b)(6).On (b)(6), awakening with a sensation of ear fullness, i used the eustachi device as directed to clear my ears.I immediately had tinnitus in my left ear and i quickly noticed that hearing in my left ear was muffled.Upon visiting an ent one week later, i learned from my audiogram i had severe hearing loss at 8khz.I was prescribed a 10-day course of prednisone, oral route.The ent did not see evidence of an eustachian tube disorder.Seeking a second opinion, i visited another ent on (b)(6).An audiogram and otoacoustic emissions test taken 4 days later yielded similar results to the previous test (severe hearing loss above 6khz).Second ent confirmed my eustachian tubes were functioning normally.Ent administered 3 intratympanic steroid injections over subsequent weeks.I have my next audiogram scheduled on (b)(6) 2021.Today, (b)(6), i still have constant, high-pitched tinnitus in my left ear and no audible recovery hearing above 6khz in my left ear.I also suffer from mild hyperacusis (sound sensitivity) in my left ear.Both audiograms show no hearing loss in right ear.Otoacoustic emissions can be detected up to 12khz in my right ear.This probably goes without saying, but tinnitus can be a very trying experience and the prospect of dealing with my current tinnitus for the rest of my life has been a cause for significant emotional stress.Recently my dentist said my experience of ear fullness may be due to an overdeveloped mastoid muscle that is putting pressure on my eustachian tubes but not actually causing them to malfunction.I am reporting this issue both because i fear that others who experience ear fullness due to neuromuscular issues but do not have a diagnosed eustachian tube disorder may be at risk of injury when using the eustachi.This product may be better suited as a device used only under the explicit direction of a healthcare professional.Left ear: the audiogram revealed i have normal, age appropriate hearing to 4khz at which point my hearing rapidly drops to -75db/-80db (very slight discrepancy between both tests) threshold at 6khz and 8khz (above 70db is rated as severe hearing loss).Right ear: audiogram reveals i have excellent hearing in my right ear.Next audiogram will be administered on (b)(6) 2021.Healthy, non-smoking individual.I rarely have more than 4 alcoholic drinks a week.I am a teacher, so i am rarely exposed to sounds that might make me vulnerable to noise-induced hearing loss.I always wear hearing protection when using power tools around the house and always wear earplugs when i attend a concert, which is usually not more than once a year.I always carefully monitor volume levels when listening to music on headphones or speakers.Fda safety report id # (b)(4).

• Brand Name: EUSTACHI EUSTACHIAN TUBE EXERCISER
• Type of Device: DEVICE, INFLATION, MIDDLE EAR
• Manufacturer (Section D): EXERCORE LLC.
• MDR Report Key: 12446347
• MDR Text Key: 272292078
• Report Number: MW5103784
• Device Sequence Number: 1
• Product Code: MJV
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 18058-21
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 41 YR
• Patient Weight: 61