Treatment

Has the SaluStim been clinically proven to reduce Tinnitus?

How do I use the SaluStim device?

How does the SaluStim Work?

What are the mechanisms of the treatment?

Do I have to wear it all the time?

How often do I have to use the SaluStim?

What are the side effects of this treatment?

What time of day should I use it?

What happens if I can’t feel the stimulation?

What intensity (mA) should I use?

What is the maximum intensity I should use?

Where is my User Guide?

Can I stop using medications if I decide to use this treatment?

How long until I see results?

What if I don’t respond to the treatment?

Do I need to visit the clinic / schedule an appointment?

Can I use treatment while sleeping?

Does background sound interfere with the treatment?

Does treatment have to be in one continuous session?

Who is suitable for tVNS and ST treatment?

Where can I find the Sound Therapy material?

What does the Sound Therapy (ST) do?

How should I use the ST?

Can I speak to someone on the phone about my treatment?


 

 

Shipping and Delivery

How much is shipping?

What shipping service do you use?

Can I track shipping?

How long does delivery take?

Are there any other costs with delivery?

Where do you deliver to?

 

Policies

Do you offer a warranty?

What happens if I decide I do not want to use the device after I try it?

Do you offer refunds?

Can I switch from rental to purchase?

What is your rental policy?

 

Account

How do I order?

What payment methods do you accept?

How can I manage my account?

Can I switch from rental to purchase?

Is there a discount on the purchase price if I have been renting?

 

Safety

Is this treatment suitable for me?

Can I use the device/treatment If I’m pregnant?

What are the side effects?

 

Company

Who is the Tinnitus Treatment Centre?

Who are the Helsinki Ear Institute?

Do you offer support after Purchasing/Renting?

What is the best way to contact you?

Do you have any ongoing research?

Are you investigating into treating other conditions?


 

 

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Treatment

Has the SaluStim been clinically proven to reduce Tinnitus?

The combined treatment methodology currently used by the Tinnitus Treatment Centre has been developed based on the research conducted with our partners at the Helsinki Ear Institute (HEI) in Finland. This research, as well as remote treatment of patients has found that Transcutaneous Vagus Nerve Stimulation (tVNS) and specially designed Sound Therapy (ST), when used in conjunction, can reduce a patient's tinnitus and tinnitus associated stress. Further reading on the literature in this area can be found here. A 2017 clinical safety and efficacy study was conducted using the Salustim device and can be found here.

 

How do I use the SaluStim device?

The SaluStim is a handheld, portable tVNS device that be operated from your own home or during your daily activities. A small discreet clip on electrode is placed on the tragus of the outer ear where small microcurrents then stimulate the Vagus Nerve. You can find out more detailed instructions of how to use the device in our quick start guide supplied after ordering.

 

How does the SaluStim Work?

The SaluStim works by sending small microcurrents of electricity at a specific pulse rate, width and waveform, to an electrode which clips onto the Tragus of the LEFT outer ear. Research has shown this can activate the vagus nerve in the same way as with invasive vagus nerve stimulation, through its auricular branch. We also have a comprehensive list of publications on the treatment and its historical research- here, including the clinical efficacy of noninvasive tVNS. See treatment mechanisms below.

 

What are the mechanisms of the treatment?

Stimulating the Vagus Nerve is thought to promote neural plasticity, which when paired with our specially designed sound therapy, aims to target the specific area of the brain that is implicated with tinnitus generation.

Research has shown that when tVNS is used for at least 1hr per day, the maladaptive plasticity that is thought to contribute to tinnitus may be reversed, leading to decreases in tinnitus associated loudness, stress and annoyance.

Tinnitus is also commonly associated with an overactive sympathetic nervous system (SNS); fight or flight response, which can be associated with high levels of stress, anxiety and/or tension.

Research conducted by our partners has shown that just one 15-60m tVNS session can significantly reduce SNS levels (as measured with HRV). It is thought that this is achieved through activation of the parasympathetic nervous system (PNS) which can lead to reduction in stress and anxiety levels. This activation is believed to contribute towards rebalancing of the Autonomic Nervous System.

Other documented effects of tVNS include decreased synchrony of synaptic activities in cortical regions, increased synaptic activities in components of the central autonomic system, and decreased synaptic activity in components of the limbic system, such as the amygdala and the hippocampus.

This has been thought to play a role in reducing tinnitus perception as well as the decrease in the negative emotional response. For further reading on the research, you can view literature here.

 

Do I have to wear it all the time?

No, see below.

 

How often do I have to use the SaluStim?

We recommend a minimum of 1hr per day. The Sound Therapy we provide includes 3 separate tracks that are each 30 minutes long. With a treatment time of 1-2hrs per day (simultaneous SaluStim and ST) results are usually seen in 8-12 weeks.

 

What are the side effects of this treatment?

t-VNS is a therapeutic alternative with only minor side effects. An analysis of data from over 300 patients and volunteers, who participated in studies of t-VNS, showed potential side effects that include itching, mild discomfort or pain at the stimulation site of the outer ear. These side effects usually disappear soon after stopping the stimulation. Studies with our device have reported no major side effects. 

Sound Therapy has not been shown to cause any significant long lasting adverse effects.

 

What time of day should I use it?

The Sound Therapy (ST) has been designed to be used during the morning (‘Rise’), during the day (‘Recover’) and before sleeping (‘Rest’). ST should be used simultaneously with the device.

 

What happens if I can’t feel the stimulation?             

Treatment stimulation intensity should be just below the level where it can be perceived or felt. For most people this is between 1mA -15mA. This stimulation threshold will vary from patient to patient because different people have different levels of sensitivity. Tolerance and sensitivity can also vary depending on time of day, activity levels and stress levels.

During treatment you should not be able to feel any sensation from stimulation. While you should not feel stimulation on the tragus locally during treatment, it is common to experience awareness of tVNS taking effect, such as increased relaxation.

The tragus is a sensitive area and it is important not to over-stimulate with too high an intensity or for too long a period of time. Follow the steps in the digital User Guide to find your therapeutic level before each treatment session.

 

What intensity level should I use?

Please refer to the updated instructions in our digital User Guide. Contact us if you do not have this guide. For safety and optimal use, do not exceed level 25.

 

What is the maximum intensity I should use?

For safety and optimal use, do not exceed level 25.

 

Where is my User Guide?

We supply all patients a digital User Guide when completing registration. If you did not download your User Guide during registration, please contact us and we can send you a download link.

 

Can I stop using medications if I decide to use this treatment?

We offer a complementary therapy to medical treatment. Only your consultant doctor can decide whether you can stop or reduce medications.

 

How long until I see results?

Relief from tinnitus is usually seen between 8-12 weeks when tVNS + ST have been used for 1-2 hrs daily with the recommended settings. As with any treatment each individual will respond differently and response times will vary.

 

What if I don’t respond to the treatment?

If response is not seen in 8-12 weeks, contact us and we can revise your treatment schedule and/or settings to see if you may benefit from changes in either of these. As with all therapies there can never be a guarantee of success. It is possible that some patients will not respond sufficiently to the therapy.

 

Do I need to visit the clinic / schedule an appointment?

This is not necessary, we have designed our treatment to be offered remotely. After ordering we will send you the SaluStim and Sound Therapy package along with our quick start guide. Our support team will also be available for assistance throughout the treatment process.

 

Can I use treatment while sleeping?

No, you should not use the treatment while sleeping.

 

Does background sound interfere with the treatment?

Background sound should not interfere if you are using over the ear headphones. However, if you are using speakers, it is advised that you do so in a quiet and relaxed setting.

 

Does treatment have to be in one continuous session?

There are three separate Sound Therapy (ST) tracks; ‘Rise’, ‘Recover’ and ‘Rest’.

‘Rise’ has been designed to be used during the morning, ‘Recover’ during the day and ‘Rest’ before sleeping . Listening to ST should be done simultaneously with using the device.  

Each ST track is roughly 30 minutes long. We recommend completing each track in one whole session, i.e. one whole continuous 30 minutes, and aiming to complete at least two sessions in one day at their respective times. This is a treatment schedule of at least 1hr/day. *To be used alongside the device.

 

Who is suitable for tVNS and tST treatment?

The SaluStim device is not certified for treating patients during pregnancy, or for patients with active implants (such as a cardiac pacemaker, or a cochlear implant). Do not use the SaluStim on children under the age of 18 unless under medical supervision. Electronic equipment such as EKG monitors and EKG alarms may not operate properly when SaluStim is in use. If you have any concerns we recommend that you consult with your physician before use. In patients with known myocardial disease, arrhythmias or epilepsy, SaluStim should be used only with consultation and evaluation by a physician.  

 

Where can I find the Sound Therapy material?

The Sound Therapy material is sent via a live download link in the welcome email, along with relevant instructions.

 

Is the Sound Therapy part of the device?

No, the Sound Therapy is provided separately via digital download, to be played on any media playing device, such as a smartphone, laptop, tablet, computer or mp3 player. It is to be played via over the ear headphones or speakers, in order to not interfere with the earclip electrode.

 

What does the Sound Therapy (ST) do?

Our Sound Therapy is specially designed to work in with the SaluStim to reduce symptoms associated with Tinnitus.

 

How should I use the ST?

The Sound Therapy should be used simultaneously with the SaluStim device. This can be achieved by using over the ear headphones or using speakers in a quiet and calm environment.

 

Can I speak to someone on the phone about my treatment?

Of course, we are here to help. You can reach us on 020 3695 8735.

 

Shipping and Delivery

How much is Shipping?

UK: Free

International (outside the UK): £25

 

What shipping service do you use?

UK: Royal Mail Special Delivery (Tracked & Signed)

International: UPS & FedEx (Tracked & Signed)

 

Can I track shipping?

Yes, just contact us to ask.

 

How long does delivery take?

UK: (1-2 working days)

Europe: (Usually under 5 working days)

Outside of Europe: (Usually under 10 working days)

 

Are there any other costs with delivery?

There should not be any extra costs if you are inside the EU. If you are outside of the EU, you may be liable for import fees, which are out of our control.

 

Where do you deliver to?

We deliver to: The UK, within the EU and selected other countries, please contact if you are unsure. We cannot currently ship to the United States or Canada.

 

 

Policies

Do you offer a warranty/guarantee?

We offer a one year  warranty on the device and a three month warranty on the earclip electrode. The earclip is reuseable and can last for over a year with good care and proper use. Daily use can put strain on the earclip and it may need to be replaced sooner. Replacement earclips can be ordered from us, just contact your representative

The device is built with strict quality tests as part of manufacturing practice, each unit is also tested before it is sent out.

We also offer continued support for all our customers- you can reach out to us via email or we can arrange a call if you would like to talk through any questions you have.

 

What happens if I decide I do not want to use the device after I try it?

For purchases we offer a 30 day refund period. We will refund the full purchase cost minus any customs, shipping or handling costs incurred.

 

Do you offer refunds?

For purchases we offer a 30 day refund period. We will refund the full purchase cost minus any customs, shipping or handling costs incurred.

 

Can I switch from rental to purchase?

Yes.

 

Is there a discount on the purchase price if I have been renting?

Yes, we offer a reduction of 50% of the cost incurred through renting at the point of switching. For example, If you rent for 6 months and choose to then purchase, the reduced cost will be: £599 - (39.99 x 6)/2 = £599 - £120 = £479

See the full monthly reduction breakdown here.

 

What is your rental policy?

Rental is £39.99/month for a minimum of three months, with a rolling contract that can then be cancelled at any time or switched to purchase.

 

Account

How do I order?

You can purchase here and rent here.

 

What payment methods do you accept?

We accept all major credit and debit cards. Contact us if you have any payment questions.

 

How can I manage my account?

You can manage your account here. If you have trouble logging in, click ‘Forgot password’ and follow the instructions to reset your password and then log in. If this fails contact us.

 

Can I switch from rental to purchase?

Yes, see below for details.

 

Is there a discount on the purchase price if I have been renting?

Yes, we offer a reduction of 50% of the cost incurred through renting. For example, If you rent for 6 months and choose to then purchase, the reduced cost will be: £599 - (39.99 x 6)/2 = £599 - £120 = £479

See the full monthly reduction breakdown here.

 

Safety

Is this treatment suitable for me?

If our safety guidelines and recommended settings are followed, the SaluStim is safe to use for the treatment of Tinnitus.

t-VNS is a therapeutic alternative with only minor reported side effects. An analysis of data from over 300 patients and volunteers, who participated in studies of t-VNS, showed potential side effects that include itching, mild discomfort or pain at the stimulation site of the outer ear. These side effects usually disappear soon after stopping the stimulation.

The SaluStim device is not certified for treating patients during pregnancy, or for patients with active implants (such as a cardiac pacemaker, or a cochlear implant). Do not use SaluSTIM® on children under the age of 12 unless under medical supervision. Electronic equipment such as EKG monitors and EKG alarms may not operate properly when SaluSTIM® is in use. In patients with known myocardial disease, arrhythmias or epilepsy, SaluSTIM® should be used only with consultation and evaluation by a physician.  

 

Can I use the device/treatment If I’m pregnant?

You should not use the device when pregnant. While healthy births have been reported from patients using VNS, the safety and effectiveness of VNS during pregnancy have not been rigorously established.

 

What are the side effects?

t-VNS is a therapeutic alternative with minor side effects. An analysis of data from over 300 patients and volunteers, who participated in studies of t-VNS, showed potential side effects that include itching, mild discomfort or pain at the stimulation site of the outer ear. These side effects usually disappear soon after stopping the stimulation.

 

Company

Who is the Tinnitus Treatment Centre?

Read about our company here.

 

Who are the Helsinki Ear Institute?

The Helsinki Ear Institute are a leading European tinnitus treatment and research centre. The Tinnitus Treatment Centre has a partnership with the Helsinki Ear Institute which involves the development of medical devices for the research and treatment of Tinnitus.

 

Do you offer support after Purchasing/Renting?

Yes, we remain in contact with you after your order for the duration of your treatment process. You are also able to contact us via phone or email.

 

What is the best way to contact you?

The fastest response is usually via email, however you can also call us.

 

Do you have any ongoing research?

Yes, please get in contact if you are interested in research with our device or taking part in a trial.

 

Are you investigating into treating other conditions?

Yes, please get in contact if you are interested in research with our device or taking part in a trial.

 

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Parasym Health