Advice

Technology overview

Technology overview

This briefing describes the regulated use of the technology for the indication specified, in the setting described, and with any other specific equipment referred to. It is the responsibility of healthcare professionals to check the regulatory status of any intended use of the technology in other indications and settings.

About the technology

CE marking

The Acoustic CR Neuromodulation device was CE marked as a Class IIa medical device on 3 February 2010. The name of the device on the declaration of conformity is the ANM Tinnitus Stimulator T30CR. The CE certificate was first awarded to ANM GmbH. Neurotherapies Reset GmbH now holds the CE certificate and the manufacturing licence. Throughout this document the technology is referred to as Acoustic Coordinated Reset (CR) Neuromodulation.

Description

The Acoustic Coordinated Reset (CR) Neuromodulation system is a non‑invasive device that produces sounds delivered to the patient though earphones. The technology is thought to act by disrupting synchronous brain activity that may cause tinnitus.

The technology comprises:

  • a neurostimulator

  • medical earphones

  • a console

  • a programming station.

The matchbox‑sized neurostimulator device is programmed by an audiologist to deliver tones tailored to the individual person's tinnitus. The programming station includes a computer and software. The patient can use the console during their assessment to adjust parameters such as frequency and loudness. Once the device is programmed, the patient listens to the sounds through non‑occluding earphones (earphones that enable people to hear external sounds) during their usual activities.

Intended use

The Acoustic CR Neuromodulation device is intended to reduce tinnitus symptoms in adults aged 18 years or over with chronic tonal tinnitus through applying auditory stimuli. The device is programmed depending on the tinnitus frequency, and stimulation needs to be applied for several hours a day over weeks or months.

Setting and intended user

The Acoustic CR Neuromodulation device should be fitted by a trained audiologist in an audiology clinic. The manufacturer provides training to clinicians before fitting the device. The audiologist uses the console and software developed by the manufacturer to programme the device to match the patient's tinnitus tones. The patient is then given a device and earphones to use for between 4 and 6 hours daily, tapering off over 4–6 months of treatment. People can use the device while going about their usual daily activities. During the course of treatment the tone of the tinnitus may change, and further consultations with an audiologist to reprogramme the device are likely to be needed.

Current NHS options

There is currently no cure for tinnitus and treatment options have varying degrees of success. The evidence for the clinical effectiveness of treatments available on the NHS is limited (Hoare et al. 2012). Most tinnitus therapies focus on habituation of reaction or perception of the sound.

If hearing loss accompanies the tinnitus it may be appropriate to fit a hearing aid. This may partially mask the tinnitus sound, distracting the patient away from tinnitus towards unrelated sounds, and reduce stress by improving communication. Patients may also use sound therapy or sound enrichment. This makes the tinnitus less noticeable by masking the unwanted sound with white noise or relaxing sounds.

Counselling or cognitive behavioural therapy (CBT) teaches people techniques to better cope with tinnitus and reduce their anxiety and depressed thoughts. Tinnitus retraining therapy is an intensive therapy that is not routinely commissioned in the NHS; nevertheless, most audiologists use elements of tinnitus retraining therapy such as a combination of sound therapy and counselling to help people focus away from the condition. In some cases drugs such as antidepressants or sedatives may be appropriate (Hobson et al. 2013).

A Good Practice Guide for the provision of tinnitus services, published by the Department of Health in 2009, recommends that patients should be referred to an audiology service in cases too severe to be managed with advice and information and those not caused by ear wax or infection (Department of Health 2009). The guide states that audiology services should offer tinnitus management through a variety of measures, including information and education, hearing aids, psychological support, relaxation therapy, CBT, sleep management, sound enrichment therapy, and tinnitus retraining therapy.

A national survey of tinnitus management in England (Hoare et al. 2012) reported that most patients in audiology departments receive an audiology‑based intervention, such as a hearing aid or sound generator.

A tinnitus quality standard has been referred to NICE (see the Library of NICE quality standards).

NICE is not aware of other CE marked devices that have a similar function to the Acoustic CR Neuromodulation.

Costs and use of the technology

The following are list prices provided by the device manufacturer for March 2014 (excluding VAT):

  • Acoustic CR Neuromodulation device including medical earphones: £1850.

  • Programming station: £1500.

  • Rechargeable batteries: £20.

  • Domes: £5.

  • Wax guards: £6.

The manufacturer anticipates that these list prices would be reduced if the NHS were to purchase multiple units.

The expected life service of the Acoustic CR Neuromodulation device is 3 years. Each device is currently used for a single patient only (having been individually calibrated during treatment visits), but the manufacturer is investigating the device's reusability for multiple patients.

The programming station has an expected life service of 5 years and can be used for multiple devices. Annual calibration is recommended for each programming station. The medical earphones, domes and wax guards can be used multiple times for a single patient. Rechargeable batteries have an expected device life of 2 years, and are currently used for a single device. The manufacturer anticipates that a service contract would be negotiated for providing the system to NHS clinics. No costs are available for an NHS service contract, but the manufacturer anticipates that such a contract would include the following as a minimum:

  • set up and initial training (5 days)

  • annual calibration and annual quality assurance audits

  • ongoing clinical support contract

  • instruction manuals and information.

Currently, no NHS services offer Acoustic CR Neuromodulation. However, independent sector provider The Tinnitus Clinic offers treatment with the device and accepts NHS referrals for Acoustic CR Neuromodulation.

The following average national costs for NHS audiology services include interventions that are likely to be standard care for people with tinnitus (NHS reference costs 2012 to 2013):

  • Fitting of hearing aids and counselling (assessment): £65 (AS1A).

  • Fitting of hearing aids and counselling (fitting): £65 (AS1FA).

  • Fitting of hearing aids and counselling (follow‑up): £54 (AS1FU).

  • Counselling and issue of aids for tinnitus: £84 (AS2).

  • Hearing aid repairs: £26 (AS3X).

  • Digital hearing aids: £85 (DHA1).

The cost to the NHS of fitting a hearing aid in an audiology clinic would include at least an assessment appointment, a digital hearing aid, fitting of the device, advice and counselling, a follow‑up visit (possibly several), and possibly multiple repairs to the hearing aid. If people need hearing aids in both ears (binaural), the costs are likely to be substantially higher.

The average national cost for a single CBT session (not specifically for tinnitus) is £157 (AB11z). Several sessions are likely to be needed for tinnitus treatment.

The British Tinnitus Association offers sound enrichment devices for purchase by patients from £35 to £49.

The Acoustic CR Neuromodulation system is also available privately. The Tinnitus Clinic supplies a treatment package for purchase directly by patients which includes the device, medical earphones, rechargeable battery, battery charger, 1 fitting appointment, 5 recalibration appointments, counselling, and an information package for £4495 including VAT.

Likely place in therapy

Acoustic CR Neuromodulation could be offered to adults with persistent subjective tonal tinnitus referred for treatment to an audiologist by their GP. An audiologist is needed to provide treatment with Acoustic CR Neuromodulation at an audiology clinic. An ear, nose and throat consultant may be needed to confirm suitability of treatment, and to rule out any need for medical or surgical intervention.

To enable the provision of Acoustic CR Neuromodulation, an NHS audiology clinic would need to purchase at least 1 programming station and training for all audiologists who would use the device. Each patient would need an Acoustic CR Neuromodulation device with earphones, rechargeable batteries, domes and wax guards. It is anticipated that other facilities that are needed to provide Acoustic CR Neuromodulation would already be available in an NHS audiology clinic.

Acoustic CR Neuromodulation treatment is expected to be delivered alongside supporting tinnitus therapies such as habituation counselling, sound enrichment and relaxation exercises. In people for whom tinnitus is associated with hearing loss, a hearing aid may also be needed. Notably, hearing aids cannot be worn during treatment with Acoustic CR Neuromodulation (that is, the devices cannot be worn at the same time).

Specialist commentator comments

One specialist commentator stated that the clinical significance of the results from Tass et al. (2012) is unconvincing. The outcome measure of loudness as measured on a visual analogue scale is not clinically relevant, and neither is the 4‑point difference in Tinnitus Questionnaire scores between group 1 and placebo. Furthermore the adverse event rate in this study appeared unacceptably high. Further well‑designed studies that are independent of the device manufacturer are needed, and publication of the RESET2 study would provide valuable evidence on this technology.

The specialist commentators stated that Acoustic CR Neuromodulation is not suitable for many people with tinnitus because they have atonal tinnitus, tinnitus that is of too high frequency for the device to deliver good quality sound stimuli, or they have too much hearing loss around the region of their tinnitus pitch to be able to hear all the stimuli. The specialist commentators considered the treatment to be suitable for approximately 20–25% of people assessed. It is not clear how people who need a hearing aid would manage treatment with Acoustic CR Neuromodulation as it cannot be used at the same time as a hearing aid.

The effective selection of patients is an important consideration. A specialist commentator stated that people with 1 or at most 2 identified tinnitus tones, constant tinnitus perception with little improvement over the previous 3 months, and hearing loss no greater than 35 dB hearing level (dBHL) average in the best ear would respond best to the treatment. Another specialist commentator noted that there was not enough evidence to support this treatment protocol, and that reliable pitch identification can be difficult.

The device appears expensive compared with other equally effective if not better tinnitus treatment strategies, including CBT. Acoustic CR Neuromodulation is currently delivered (by a private provider) as a package including counselling and stress management; it is uncertain if NHS audiology services would offer the same level of service.

The current design of the device is suitable for a single use only. Acoustic CR Neuromodulation was used for 9 months in the RESET2 study (Hoare et al. 2013), rather than the 4–6 months suggested by the manufacturer.

One specialist commentator suggested that 6 hours of clinical time with a senior audiologist and or hearing therapist would be needed to fit binaural hearing aids. Another specialist estimated that 2 visits lasting 2.5 hours in total would be needed for fitting binaural hearing aids. The patient may have a follow‑up appointment or be followed up by telephone, depending on the department.

Equality considerations

NICE is committed to promoting equality and eliminating discrimination. As a public authority NICE must also comply fully with legal obligations to promote race and disability equality and equality of opportunity between men and women; and to eliminate unlawful discrimination on the grounds of race, disability, age, sex and gender, sexual orientation, and religion or belief. This is in accordance with the NICE Equality Scheme.

Age is a protected characteristic defined in the Equality Act 2010. Treatment of tinnitus with this technology may allow older people with hearing problems caused by tinnitus to have a better quality of life and participate more in society.

Patient and carer perspective

Any new treatment which alleviates the symptoms associated with tinnitus would be beneficial to patients and carers. Further information on the usability of the Acoustic CR Neuromodulation device would be helpful; if the device is difficult to use then this may affect patients' adherence to the treatment regime.