Ear-level instrumentation in the treatment of tinnitus

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Ear-level instrumentation in the treatment of tinnitus Pawel J. Jastreboff, Ph.D., Sc.D., M.B.A. Professor Department of Otolaryngology Emory University School of Medicine Atlanta, GA pjastre@emory.edu www.tinnitus-pjj.com Disclosure Statement: No relevant financial or non-financial relationships to disclose Jastreboff, 2014 2

Sound is important to our well being and for correct functioning of our auditory system Sounds in daily environment Sounds of nature Voices Music Jastreboff, 2014 3

Music and / or sounds of nature are recognized to help Reduce stress With sleep problems Promote learning, including helping dyslexia Induce positive changes in cognitive function In recovery from traumatic events including health problem (cardiac operation) Jastreboff, 2014 4

Is tinnitus a real physical sound? Are rules governing interaction of tinnitus with external sounds the same as for two external sounds? db SPL NO!!! Two external sounds Tinnitus Critical band Therefore frequency There is no vibratory activity in the cochlea corresponding to tinnitus perception and thus Tinnitus is a phantom auditory perception Jastreboff, 2014 5

Patients comments about perception of tinnitus Tinnitus is loud Tinnitus takes my attention from other sounds and things I should be doing Tinnitus causes that I cannot understand people Tinnitus is getting louder when I am in quiet Tinnitus is getting louder when I am exposed to loud sound Jastreboff, 2014 6

Use of sound in tinnitus treatment Sound is an important part of many tinnitus treatments; it is used to: Cover-up (masking) Achieve immediate relief Distract attention from monitoring tinnitus Decrease stress Help with sleep Decrease the difference between the tinnitus signal and background neuronal activity (principle used in Tinnitus Retraining Therapy - TRT) Jastreboff, 2014 7

How sound is used When tinnitus annoying A few times a day As an exercise in set times When convenient All the time Jastreboff, 2014 8

Use of ear level instrument for tinnitus in the past Ear level instrument started to be used in tinnitus therapy over 30 years ago Hearing aids Maskers What have we learned from past experiences? Jastreboff, 2014 9

Ear level instruments, such as sound generators (SG), hearing aids (HA), combination instruments (Combi), can be very helpful and an important part of tinnitus treatment However, alone these devices are seldom the solution for high level tinnitus control and should always be utilized in conjunction with counseling; proper counseling is an essential part of any effective tinnitus treatment protocol Jastreboff, 2014 10

Practically everybody experience tinnitus when put in sufficiently quiet environment for some time Many people report having tinnitus, but only small proportion of people hearing tinnitus is bothered by it Why tinnitus is bothersome only to some people? Jastreboff, 2014 11

Observation Lack of relationship between psychoacoustical description of tinnitus, its severity and treatment outcome Conclusion Auditory system plays a secondary role in clinically-relevant tinnitus; other systems in the brain are dominant Complains of tinnitus patients point out systems which might be involved Jastreboff, 2014 12

The Neurophysiological Model of Tinnitus Processing of tinnitus-related signal within various parts of the central nervous system has to be included in the analysis of the phenomenon of bothersome (clinicallysignificant) tinnitus Jastreboff, 2014 13

Perception & Evaluation Auditory & other Cortical Areas Detection Subcortical Emotional Associations Limbic System Source Cochlea Annoyance Autonomic Nervous System Jastreboff, 2014 14

Perception & Evaluation Auditory & other Cortical Areas H E Detection Subcortical H E Emotional Associations Limbic System H R Source Cochlea Annoyance Autonomic Nervous System Jastreboff, 2014 15

Perception & Evaluation Auditory & other Cortical Areas H P H E Detection Subcortical HE Emotional Associations Limbic System H R Source Cochlea Annoyance Autonomic Nervous System Jastreboff, 2014 16

Techniques to achieve habituation Reclassify tinnitus to category of neutral stimuli Retraining COUNSELING Decrease strength of tinnitus-related neuronal activity SOUND THERAPY Jastreboff, 2014 17

Principles of using sound in TRT Sound used as a part of sound therapy in TRT should never induce annoyance or any kind of negative reaction from the patient, as this would increase the activation of the autonomic and limbic nervous systems, and consequently may prevent habituation from occurring Systematic masking should be avoided Sound level should be above range of stochastic resonance Improve hearing abilities with amplification, when needed Consistent increased stimulation with sounds decreases gain within the auditory system Current TRT protocol is geared toward using at least two types of sound Sounds of nature, particularly water Broadband noise Music is used in majority of patients, mainly as element of protocols for misophonia Jastreboff, 2014 18

Effects of silence on tinnitus It has been shown that practically everyone develops temporary tinnitus, if put in an extremely quiet environment: It is so quiet that ears are ringing As a rule, patients with tinnitus find that their tinnitus seems much louder and more intrusive in a quiet room or when their ears are blocked The gain in the auditory system increases resulting in enhancement of the tinnitus signal It is crucial to have an enriched sound environment together with sound provided by ear-level instruments The sound of the instruments provides safety net Avoid silence! Jastreboff, 2014 19

Principles of perception of strength of a signal All of our senses reacts not to the absolute value of a stimulus, but to the difference between the stimulus and background The strength of any signal in the nervous system is related to its difference with background neuronal activity By increasing background neuronal activity, it is possible to effectively decrease the strength of tinnitus-related neuronal activity within the auditory pathways and consequently in all systems involved Jastreboff, 2014 20

Strength of tinnitus signal depends on its difference from a background TINNITUS BACKGROUND TINNITUS BACKGROUND Jastreboff, 2014 21

The role of sound therapy in TRT Decrease contrast between tinnitus and background neuronal activity Interfere with the brain s ability to detect the tinnitus signal Reduce abnormal gain in the auditory system Increase frequency range of the stimulation of the auditory system Preserve or restore symmetry of stimulation of the auditory system Improve communication ability Decrease the strain-to-hear Decrease focus on the ear and sound perception Increase patient s sense of control Decrease general stress caused by tinnitus Jastreboff, 2014 22

Enhanced stimulation by sound can be provided by Environmental sounds (e.g., table-top machines, ipod, MP3 players, CDs, TV) non amplified amplified by hearing aids or combination devices Recent advances in hearing aids allow for streaming sound from ipod, MP3 players, CDs and other devices directly to hearing aids Sound generators or sound generator part of combination devices Ear level devices should be used concurrently with enhancement of the environmental sounds Jastreboff, 2014 23

Why to use ear level instruments? To facilitate the implementation of sound therapy which results in improvement of the compliance with the protocol To give a patients a sense of control and of doing something tangible (psychological aspects) About 30% of patients have hyperacusis. For these patients use of well controlled, stable sound source, such as provided by sound generators, is highly beneficial Additional positive consequence is decreasing strain-to-hear phenomenon in patients with hearing loss by using hearing aids or combination instruments Jastreboff, 2014 24

General rules for choosing instruments (in TRT) Recent tinnitus or tinnitus is not a significant concern => no instruments necessary (but still can be used) Bothersome tinnitus, no hearing loss => SGs Bothersome tinnitus and hearing loss => Combi or HAs Hyperacusis => SGs Hyperacusis & tinnitus => SGs Hyperacusis & tinnitus & hearing loss => Combi Always use binaural fitting to preserve / restore the symmetry of stimulation of the auditory system Jastreboff, 2014 25

Stochastic resonance Stochastic resonance causes that weak, close to threshold signal, is better detected and it is enhanced by addition of low level noise Sound therapies with random noise are used in treatment of tinnitus and hyperacusis Results of specific study showed that, consistently with stochastic resonance, tinnitus loudness match was increased (~10%) in statistically significant manner by adding low level of noise Stochastic resonance might play a role in worsening tinnitus Performing REM is recommended Patients with misophonia are at the highest risk Jastreboff, 2014 26

Effects of Stochastic Resonance Threshold of a signal detection Signal strength Additional noise Additional noise Jastreboff, 2014 27

Change of tinnitus loudness [db] 1.4 1.2 1 0.8 0.6 0.4 0.2 0-12 -9-6 -3-0.2 0 3 6 9 12-0.4 White noise level [db SL] Jastreboff, 2014 28

Therefore, precautions should be taken not to use too low levels which could be close to the threshold levels of sound perception, as these could enhance the tinnitus signal due to the stochastic resonance. Jastreboff, 2014 29

Mixing point Tinnitus changing Annoyance Threshold of hearing Effective range of sound use Tinnitus suppressed masking Jastreboff, 95 Intensity of a sound Jastreboff, 2014 30

FACILITATION Effectiveness of habituation Mixing point Effective range of sound Annoyance Suppression ( masking ) INHIBITION -10 10 20 30 Sound intensity [db SL] Stochastic resonance Jastreboff, 2014 31

Sound generators Should be used only for patients who have normal hearing Can be used for tinnitus and / or hyperacusis and as a part of protocols for misophonia Particularly needed for cases with hyperacusis Must provide control of the sound level used to patients Used in past smooth change of sound level has been replaced by an increase by pre-set value (toggle or remote-controlled step value) Shaping of the sound spectrum is needed for improving the acceptance of a sound by patients Jastreboff, 2014 32

History of sound generators Viennatone Silent Star characteristics like old AM/Ti, but better cosmetic appeal - still available in Europe GHI in-the-ear or OTE - smoother and expanded in high frequency region frequency characteristics Audifon / Kind, Hansaton, other companies Currently, due to decrease of prices of combination devices they can be used as sound generators Jastreboff, 2014 33

Viennatone AMTi Jastreboff, 2014 34

Silent Star Jastreboff, 2014 35

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Real Ear Measurements (in Tinnitus Retraining Therapy) Verbal reports are not sufficient to determine sound levels used by patients during treatment Modified Real Ear Measurements (REM) of the sound level in the ear canal were performed to: To measure sound level used by patients at the beginning of the treatment To determine potential changes in sound levels during treatment, To determine potential differences in sound setting between tinnitus only and hyperacusis patients Jastreboff, 2014 38

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Average sound level used by the patients was ~11 db SL (Re: threshold of perception of the sound produced by SG - range from 0 to 20 db SL) This sound level should not interfere with speech perception, except in cases with significant hearing loss in frequency range of 1 khz to 3 khz There is no difference in setting sound generators between patients with tinnitus only, and patients with tinnitus and hyperacusis The comfort level for noise provided by sound generators appears to be the factor determining sound level used by patients REM measurements decrease the risk of the use of sound levels within the range of stochastic resonance or overstimulation REM is highly recommended as a part of TRT protocol Jastreboff, 2014 40

Tinnitus Retraining Therapy Volume Control Taper Sound Pressure Level (db at 3kHz) 70 60 50 40 30 20 10 0 0 10 20 30 40 50 60 70 80 90 100 Percent CW Rotation (%) Jastreboff, 2014 41

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Tinnitus Retraining Therapy Frequency Response Jastreboff, 2014 43

Instruction for setting SGs in TRT - tinnitus Sound should not create annoyance or problems because of any reason! Goal for tinnitus patient is mixing point Step method is recommended Avoid consistent masking of tinnitus; short periods of masking are not important Volume of sound generators should be stable kept at the same level regardless of behavior of tinnitus or listening environment during the block of usage Recommended sound level 6 to 20 db SL Jastreboff, 2014 44

FACILITATION Effectiveness of habituation Mixing point Effective range of sound Annoyance Suppression ( masking ) INHIBITION -10 10 20 30 Sound intensity [db SL] Stochastic resonance Jastreboff, 2014 45

Use of hearing aids in sound therapy (present hearing loss) Commonly they are first type of instrumentation used as 80% of tinnitus patients have some hearing loss Hearing aids are implemented to expand stimulation of auditory system and secondarily to alleviate strain to hear Aids are implemented primarily for tinnitus treatment, communication is a secondary benefit Aids should be worn during all waking hours Enrichment of environmental sound is crucial May mask tinnitus Limited effectiveness, if not used as a part of specific program of treatment and sound use Jastreboff, 2014 46

Setting Hearing Aids - tinnitus fitting Patient is gradually eased into amplification The aim is to provide amplification above 6 khz (through gradual process) More stress on high quality of amplified sound Recommendation to disable all noise reduction features Automatic adaptive functions are to be used with caution Some patients may require volume control due to misophonia or psychological reasons Jastreboff, 2014 47

Unilateral losses Approach is based on multisensory integration of auditory and visual systems CROS BiCROS Stress on impact of hearing loss on the auditory system Plasticity Improved symmetry of stimulation External sound enrichment is crucial Jastreboff, 2014 48

Combination instruments (in TRT) Adding a noise produced by SGs may negatively influence speech discrimination in patients with hearing loss Therefore, HA part of the Combi is used mainly to prevent decrease of speech understanding Amplification is set primary to compensate for the effect of noise introduced by SG, thus, frequently initial amplification is set below recommended target Amplification is gradually increased during subsequent appointments Patient needs to understand the rationale of implemented protocol Combination instruments may be recommended for patients whose mild hearing loss would not indicate the need to use hearing aids alone Jastreboff, 2014 49

Open fitting Recommended for all type of instruments To prevent attenuation of environmental sounds Occluding the ear canal makes tinnitus worse Jastreboff, 2014 50

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Selected list of companies offering tinnitus-orieted ear-level devices Amplisound Audifon General Hearing Instruments GN ReSound Hansaton Oticon Phonak Siemens Starkey Unitron Widex Jastreboff, 2014 52

Amplisound Quell TINNITUS DEVICESFDA 510(k): K132965 Features Interchangable soundtips available in 4 lengths. Available in beige or taupe Suggested Fitting Range Locking handle for a secure and comfortable fit Domes available in 3 sizes db HL Easy to use scrolling volume wheel. 0dB at minimum. On/Off Switch in VC. Frequency in Hz #10 battery (90 hours) Manufactured by Amplisound solacefortinnitus.net Jastreboff, 2014 53

Quell TINNITUS DEVICES FDA 510(k): K132965 Quell tinnitus devices offer a reliable and affordable solution for sound therapy by qualified tinnitus practitioners. The sound stimulus has been carefully designed for a smooth, extra broad band response. Quell tinnitus devices can be fit to the patient with the standard initial program settings. As needed, these devices can be adjusted with Hearing Studio programming software. Adjustable features include: 12 band equalizer for frequency shaping and tone quality adjustment Low battery indicator tone which is pre-set at 60 db and 500 Hz (can be turned off) Manufactured by Amplisound solacefortinnitus.net Jastreboff, 2014 54

Audifon Company well know in Germany where offers variety of instruments for tinnitus Relatively recent in the USA Promotes devices as tailored to TRT Only two devices available at the moment SG: switch TRT Combination devices: Switch 8 TRT Jastreboff, 2014 55

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General Hearing Instruments Jastreboff, 2014 57

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GN ReSound Combination devices on the market for several years Current models: Verso TS, LiNX TS (LTN961-DRW, LTN761- DRW, LTN977-DW, LNT777-DW, LNT988-DW, LNT788), ReSound LiNX TS is compatible with iphone 5s, iphone 5c, iphone 5, ipad Air, ipad (4th generation), ipad mini with Retina display, ipad mini, and ipod touch (5th generation), using ios 7.X or later. Jastreboff, 2014 60

Hansaton Private company well know in Germany Two models of the Hansaton SOUL tinnitus combination instruments: the Slim BTE and the X-mini RIC BTE in two technology levels as well: the SOUL Economy class (8 channels/8 bands), and the SOUL Business class (16 channels/ 16 bands). HANSATON SOUL systems can be operated by remote control for volume and program changing. Systems are Bluetooth enabled and allow for direct, wireless contact with the TV or stereo system. Jastreboff, 2014 61

Oticon Oticon Hearing released this year their version of tinnitus management called Tinnitus Sound Support in their Alta Pro and Nera Pro hearing aids Tinnitus SoundSupport Provides the sounds based on white, pink or red noise which can be limited in frequency by high pass or low pass filters Provides the option of amplitude modulation, a volume control and automatic level steering Generates a broadband noise signal with adjustable spectrum Jastreboff, 2014 62

Phonak Phonak Audéo V combination device is RIC portfolio for mild to severe hearing losses Four designs, three external receivers and four performance levels Running on the new operating system, AutoSense OS, Audéo V is promoted as better in automatic adaptation to listening situations than previous models Jastreboff, 2014 63

Siemens Practically all Siemens HA include sound generators and can be used as combination instruments Just introduced binax is promoted as allowing to achieve up to 25% better speech intelligibility than people with normal hearing in the same cocktail-party situation System emulates natural binaural listening by linking two binax hearing instruments using e2e wireless 3.0 data transmission technology without compromising battery life Android phones can be used as remote control for Siemens hearing aids Jastreboff, 2014 64

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Starkey Combination device - Xino Tinnitus product - include Multiflex Tinnitus Technology Multiflex Tinnitus Technology Generates a broadband noise signal with adjustable spectrum The sound can be frequency and amplitude modulated resulting in perception similar to ocean waves or a breeze SoundPoint Tinnitus feature allows to tailor the sound under the guidance of tinnitus patient Jastreboff, 2014 67

Unitron Moxi 2 and Quantum 2 combination instruments Sound generators part is available in nearly all technology levels and styles Unique aspect of their hearing aids a possibility to upgrade given model to better hearing technology levels at any time Jastreboff, 2014 68

Widex Widex promotes a technology of fractal tones, called Zen, to help relax Broad band noise can be used as well, level of which can be modified by remote control Zen is available in all DREAM and Clear technology Low-end device, Zen2Go, are promoted for tinnitus Jastreboff, 2014 69

Current changes in instrumentation for tinnitus Majority of manufacturers are offering combination instruments with broad band noise spectrum of which can be modified (e.g., Siemens, high-end Widex) Increase ease of streaming sound to devices (e.g., ReSound LiNX and iphone) Improvement in quality of CROS and BICROS wireless systems Enhanced frequency range up to 10 12 khz Wireless communication between hearing aids Jastreboff, 2014 70

Take home points Vast majority of tinnitus patients could benefit from the use of ear level instrumentation Use bilateral fitting Selection of instruments depends on the specifics of a patient; combination instruments are optimal for majority of cases The sound produced by SG (or SG part of Combi) should never evoke annoyance Sound range selected by patients varies from 0 db SL to 20 db SL; it is advisable to avoid sound levels below 6 db SL to avoid potential negative impact of stochastic resonance Jastreboff, 2014 71

Fitting of HAs should follow a specific recommendations of tinnitus fitting" which typically involves not reaching initially the target, fitting performed over several appointments and disabling noise cancelation features for main program; providing amplification above 6 khz (through gradual process) is recommended Patients with decreased sound tolerance require even more gradual introduction of amplification Sound generators worn under ear muffs are recommended for patients when ear protection is required Counseling tailored to specifics of a patient and proposed instruments is crucial to achieve high level of success Jastreboff, 2014 72

Thank you Jastreboff, 2014 73