• Study on Zzoma is included in the Best of Sleep Medicine 2011, an annual collection of scientific literature.

  • Zzoma is mentioned in the Fundamentals of Sleep Medicine.

About Zzoma: For Physicians

What is Zzoma?

The Zzoma Positional Device is an FDA-Cleared Class II (prescription only) Positional Medical Device intended for the treatment of mild to moderate positional obstructive sleep apnea (OSA). Designed by board a certified sleep physician Dr. Joseph Crocetti, Zzoma is a positioner worn around the upper torso to restrict patients from moving from the lateral to supine position. In a clinical study, Zzoma was found to be a clinically proven effective treatment for patients with positional OSA1. Download a printable information sheet for patients here.

Why Prescribe Zzoma?

  • 100% Satisfaction Guarantee (30-day Trial Period)
  • 1-Year Warranty
  • Clinically Proven
  • Physician Designed
  • FDA Cleared
  • Affordable Alternative to CPAP
  • Professional Substitute to “Tennis Balls Therapy”
  • Doesn’t Disrupt Sleep
  • FREE SHIPPING in the United States

Prescribing Zzoma:

  1. Please fill out a prescription for “Zzoma” with diagnostic code G47.33.
  2. Fax prescription to 1.267.222.1000 OR email to info@2zmedical.com.
  3. Refer patients to www.ZzomaOsa.com or 1.877.799.9662 to purchase Zzoma.
  4. Zzoma is generally an out-of-pocket expense ($189.95).

The 2009 AASM guidelines relating to treatment of positional therapy state:

“Positional therapy, consisting of a method that keeps the patient in a non-supine po­sition, is an effective secondary therapy or can be a supplement to primary therapies for OSA in patients who have a low AHI in the non-supine versus that in the supine position (Guideline).21 Because not all patients normalize AHI when non-supine, cor­rection of OSA by position should be documented with PSG before initiating this form of treatment as a primary therapy (Consensus). A positioning device (e.g., alarm, pillow, back­pack, tennis ball) should be used when initiating positional therapy (Consensus). To establish the efficacy of a positioning device in the home, providers should consider use of an objec­tive position monitor (Consensus). Treatment specific outcome indicators to monitor with therapy include: self-reported com­pliance, objective position monitoring, side effects, and symp­tom resolution (Consensus).”

An effective, comfortable and affordable CPAP alternative:

In a multi-center clinical study2 of patients with positional OSA, Zzoma was as effective as continuous positive airway pressure (CPAP) at:

  • Normalizing and effectively treating their OSA
  • Improving blood oxygen levels during sleep
  • Maintaining sleep quality
  • Normalizing the apnea-hypopnea index (AHI) to less than 5 events per hour
  • Decreasing the AHI by over 50%

With CPAP compliance rates below 50%3, you can prescribe Zzoma as a great alternative for patients who struggle to properly adjust to CPAP treatment due to factors like claustrophobia, mask discomfort, nasal congestion and/or eye irritation. Zzoma is also an affordable alternative to CPAP therapy.

When compared with baseline, both therapies significantly decreased the AHI (*p < 0.001), with a significant difference between the 2 treatments (tp < 0.001). (Above) Comparison of the percentage of total sleep time spent supine compared with Baseline, CPAP and PD (Above)
Percentage of total sleep time during the 4 stages of rest—comparison of Baseline, CPAP and Positional Device. N1 refers to the sleep stage 1; N2, sleep stage 2; N3, sleep stage 3; REM, repaid eye movement sleep. (Above) The Apnea Hypopnea Index comparison of Baseline, CPAP and Zzoma Positional Device.

 

 

 

 

 

 

 

    .For more information, visit our FAQ page or contact us with any additional questions. You may also request an office Sample.

References

Navigating the Insurance Reimbursement Process

Zzoma is an out-of-pocket expense that you may be refunded for by your private healthcare insurer. Refund approval and percentage depends on your policy.

If you'd like to receive pre-approval we suggest for you to start by calling the 800 # on the back of your insurance card. Ask them their policy on the equipment code E1399 as a medical necessity. Explain to the customer care representative that you have been diagnosed with obstructive sleep apnea and have been prescribed Zzoma as a medical device. Let them know that you do have a medical necessity letter (click for a sample).

Most insurance companies will have you purchase items and then download a claim form from their website. We suggest submitting a copy of your prescription, medical necessity letter and receipt with your form. We are not given permission to access your health coverage so please be sure to write your own address on the forms for correspondence.

The following information is a collection of the details you may need for your refund.

Manufacturer/Servicing Provider Name: Sleep Specialists, LLC (DBA 2Z Medical)
TAX ID: 20-5914787
Physical Address: 45 E City Ave PMB 325 Bala Cynwyd PA 19004
Telephone: 1.877.799.9662
Fax: 1.267.222.1000
Active HCPCS Code/Equipment Code & Description: E1399 Durable Medical Equipment Misc Code
Production Name: Zzoma Positional Device
Regulatory Class: II (prescription only)
FDA Clearance 510(k): K100160
ICD-9 Diagnosis Code: 327.23 or Obstructive Sleep Apnea

If your insurance company does not cover for Zzoma, it may be covered under your pre-tax cafeteria plan (IRS Section 125).

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Navigating the Insurance Reimbursement Process

Zzoma is an out-of-pocket expense that you may be refunded for by your private healthcare insurer. Refund approval and percentage depends on your policy.

If you'd like to receive pre-approval we suggest for you to start by calling the 800 # on the back of your insurance card. Ask them their policy on the equipment code E1399 as a medical necessity. Explain to the customer care representative that you have been diagnosed with obstructive sleep apnea and have been prescribed Zzoma as a medical device. Let them know that you do have a medical necessity letter (click for a sample).

Most insurance companies will have you purchase items and then download a claim form from their website. We suggest submitting a copy of your prescription, medical necessity letter and receipt with your form. We are not given permission to access your health coverage so please be sure to write your own address on the forms for correspondence.

The following information is a collection of the details you may need for your refund.

Manufacturer/Servicing Provider Name: Sleep Specialists, LLC (DBA 2Z Medical)
TAX ID: 20-5914787
Physical Address: 45 E City Ave PMB 325 Bala Cynwyd PA 19004
Telephone: 1.877.799.9662
Fax: 1.267.222.1000
Active HCPCS Code/Equipment Code & Description: E1399 Durable Medical Equipment Misc Code
Production Name: Zzoma Positional Device
Regulatory Class: II (prescription only)
FDA Clearance 510(k): K100160
ICD-9 Diagnosis Code: 327.23 or Obstructive Sleep Apnea

If your insurance company does not cover for Zzoma, it may be covered under your pre-tax cafeteria plan (IRS Section 125).

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Zzoma Application Instructions:

Warning:
The user of this pillow should consult with their physician if the following symptoms continue:

Contraindictions:

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Cleaning Instructions:

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