DizzyFIX

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The DizzyFIX device and hat

The DizzyFIX is an FDA cleared home medical device available to assist in the treatment of Benign paroxysmal positional vertigo (BPPV) and its associated vertigo.[1] The device itself is a head-worn representation of semi-circular canals. The device is filled with fluid and a particle representing the otoconia (loose hard particles) associated with BPPV. The device works like a visual set of instructions and guides the user through the treatment maneuver for BPPV. This maneuver is called the particle repositioning maneuver or Epley maneuver.

BPPV[edit]

Main article: BPPV
Nystagmus.

BPPV is the most common cause of peripheral vertigo.[2] It can be characterized by three main symptoms: positional onset, spinning dizziness and short lived symptoms. The primary diagnostic maneuver is the Dix-Hallpike which elicits the cardinal sign associated with BPPV, rotatory nystagmus.

Background[edit]

The DizzyFIX was originally developed by otolaryngologists (ENT physicians) to assist in the long term treatment of patients with a known history of recurrent BPPV.[citation needed] BPPV is frequently highly recurrent with rates as high as 50%.[3] Radtke et al. have suggested that home treatment is both safe and effective when training is adequate but that the key cause of failure of the home treatment is an imperfect repositioning maneuver.[4] As a result of failed home treatments the DizzyFIX was developed to assist patients in the performance of a correct particle repositioning maneuver. Research to date indicates that use of the device is correlated with a correct particle repositioning maneuver.[1]

Research[edit]

Bromwich et al. measured the impact that DizzyFIX had on volunteers' ability to perform the Epley maneuver. Reports indicated that the DizzyFIX improves accuracy by comparison to instructions and expert training alone. [5]

Research dealing with the design and clinical application of the device was published in the July edition of Archives of Otolaryngology. The researchers gave the DizzyFIX to 40 patients suffering from BPPV. After one week of home treatment, 35 patients (88 percent) had no evidence of nystagmus with Dix-Hallpike maneuvers, a rate "comparable to standard treatment."[6]

Device certification[edit]

  • The DizzyFIX is FDA cleared for use in the USA.(K081602)
  • The DizzyFIX is CE registered in the European Union.
  • The DizzyFIX device is a Class I medical device according to Rule 7(1) of the Medical Devices Regulations and has been reviewed and determined to be such by the Device Licensing section of the Medical Devices Bureau of Health Canada.
  • The DizzyFIX complies with Canada's Medical Devices Regulations, which include: safety and effectiveness (Sections 10 to 20, 21 to 23, 52 to 58, 59 to 62, and 63 to 65). It also complies with the requirements of Sections 3 and 19 to 21 of Canada's Food and Drugs Act.

See also[edit]

References[edit]

  1. ^ a b Beyea, Jason Atkins; Wong, Eric; Bromwich, Matthew; Weston, W Wayne; Fung, Kevin (2008). "Evaluation of a Particle Repositioning Maneuver Web-Based Teaching Module". The Laryngoscope 118 (1): 175–80. doi:10.1097/MLG.0b013e31814b290d. PMID 18251035. 
  2. ^ Nedzelski, JM; Barber, HO; McIlmoyl, L (1986). "Diagnoses in a dizziness unit". The Journal of otolaryngology 15 (2): 101–4. PMID 3712537. 
  3. ^ Nunez, Robert A.; Cass, Stephen P.; Furman, Joseph M. (2000). "Short- and long-term outcomes of canalith repositioning for benign paroxysmal positional vertigo". Otolaryngology - Head and Neck Surgery 122 (5): 647–52. doi:10.1016/S0194-5998(00)70190-2. PMID 10793340. 
  4. ^ Radtke, A.; Von Brevern, M.; Tiel-Wilck, K.; Mainz-Perchalla, A.; Neuhauser, H.; Lempert, T. (2004). "Self-treatment of benign paroxysmal positional vertigo: Semont maneuver vs Epley procedure". Neurology 63 (1): 150–2. doi:10.1212/01.WNL.0000130250.62842.C9. PMID 15249626. 
  5. ^ Bromwich, MA; Parnes, LS (2008). "The DizzyFix: Initial results of a new dynamic visual device for the home treatment of benign paroxysmal positional vertigo". Journal of otolaryngology 37 (3): 380–7. PMID 19128643. 
  6. ^ Bromwich, M.; Hughes, B.; Raymond, M.; Sukerman, S.; Parnes, L. (2010). "Efficacy of a New Home Treatment Device for Benign Paroxysmal Positional Vertigo". Archives of Otolaryngology - Head and Neck Surgery 136 (7): 682–5. doi:10.1001/archoto.2010.105. PMID 20644063. 

External links[edit]