AUDIOLOGY Tinnitus

- Acknowledgements

Chief Editor: Reda Kamel1 ‎

General Secretary: Ahmed Ragab2 ‎

General Coordinator: Baliegh Hamdy3 ‎

Scientific Board: Ashraf Khaled,4 Mohamed Ghonaim,5 Mahmoud Abdel Aziz,6 Tarek ‎Ghanoum,7 Mahmoud Yousef8 ‎

Audiology Chief Manager: Tarek Ghannoun7

Audiology Executive Manager: Iman El-Danasoury9

Assembly Board: Mohamed Tarek Ghannoum,7 Abeir Osman Dabbous,7 Mohamed Moustafa Abdeltawwab10

Grading Board (In alphabetical order): Rafeek Mohamed Abdel-Kader,11 Iman Mostafa Basiouny,12 Mona El-Akkad,13, Mohamed El-Badry,11 Iman Sadek El-Danasoury,9 Tarek El-Dessouky,12 Amira Maged El-Shennawy,7 Nagwa Hazzaa,9 Naema Ismail,14 Enaas Kolkaila,15 Rabab Ahmed Koura,12 Radwa Mahmoud,16 Salwa Mahmoud,17 Soha Mekki,18 Mona Mourad,19 Nashwa Nada,15 Adel Abdel Maksoud Nassar,9 Reham Rafei,13 Fatma Mohammed Refat,11 Mostafa Aly Youssif20

Reviewing Board: Nadia Kamal,9 Osama Sobhy,19 Mohamed Salama Bakr21, Nevin Mohei Shalaby22 Omnia Ahmed Raafat23 Kareem Mohsen Moussa24, Dalia Salah Eldin Elmesidy24

Ministry of health ECPG steering committee: Reda Kamel1, Ahmed Ragab2, ‎Mahmoud Abdelaziz6, Mohamed Elsheikh6, Sherif Guindi25, Ali Mahrous26, Louay ‎Sharkawy1, Saad Elzayat27, Ahmed Abu Elwafa28, Iman El-Danasoury9, Mahmoud Yousef8, ‎Samir Halim29, Ahmed Mustafa30, Ehab Seifein 30, Ashraf Lotfy31, Mohamed ‎Eltokhy32, Tamer Azzam32‎

1Otorhinolaryngology Department, Faculty of Medicine/ Cairo University, 2Otorhinolaryngology Department, Faculty of Medicine/ Menoufia University, 3Otorhinolaryngology Department, Faculty of Medicine/ Minia University, 4Otorhinolaryngology Department, Faculty of Medicine/ Beni-Suef University, 5Otorhinolaryngology Department, Faculty of Medicine/Mansoura University, 6Otorhinolaryngology Department, Faculty of Medicine/ Tanta University, 7Audio-vestibular Medicine Unit, Otorhinolaryngology Department, Faculty of Medicine/ Cairo University, 8Phoniatrics Unit, Otorhinolaryngology Department, Faculty of Medicine/ Ain Shams University, 9Audio-vestibular Medicine Unit, Otorhinolaryngology Department, Faculty of Medicine/ Ain Shams University, 10Audio-vestibular Medicine Unit, Otorhinolaryngology Department, Faculty of Medicine/ Mansoura University, 11Audio-vestibular Medicine Unit, Otorhinolaryngology Department, Faculty of Medicine/Minia University, 12Audio-vestibular Medicine Unit, Otorhinolaryngology Department, Faculty of Medicine/ Beni-Suef University, 13Audio-vestibular Medicine Unit, Otorhinolaryngology Department, Faculty of Medicine/ Fayoum University, 14Audio-vestibular Medicine Unit, Otorhinolaryngology Department, Faculty of Medicine/ Al Azhar University, 15Audio-vestibular Medicine Unit, Otorhinolaryngology Department, Faculty of Medicine/ Tanta University, 16Audio-vestibular Medicine Unit, Otorhinolaryngology Department, Faculty of Medicine/ Benha University, 17Audio-vestibular Medicine Unit, Otorhinolaryngology Department/ Hearing and Speech Institute, 18Audio-vestibular Unit, Otorhinolaryngology Department, Faculty of Medicine/ Zagazig University, 19Audio-vestibular Medicine Unit, Otorhinolaryngology Department, Faculty of Medicine/ Alexandria University, 20Audio-vestibular Medicine Unit, Otorhinolaryngology Department, Faculty of Medicine/ Sohag University, 21Audio-vestibular Medicine Unit, Otorhinolaryngology Department, Faculty of Medicine/ Assiut University, 22 Neurology Department, Faculty of Medicine/ Cairo University, 23Psychiatry Department, Faculty of Medicine/ Cairo University, 24Radiology Department, Faculty of Medicine/ Cairo University. 25Otorhinolaryngology Department, Faculty of Medicine/ Fayoum University, 26Otorhinolaryngology Dep. Faculty of Medicine/Al Azhar University, 27Otorhinolaryngology Dep. Faculty of Medicine/Kafr El Shiekh University, 28 Otorhinolaryngology Department, Faculty of Medicine/ Assiut University, 29Otorhinolaryngology Department Mataria Teaching Hospital, ‎‎30Otorhinolaryngology Department, Faculty of Medicine/ Hearing and Speech ‎Institute, 31Otorhinolaryngology Department Secretariat of the Ministry of Defense, ‎‎32Otorhinolaryngology Department Ministry of Interior Medical Services Sector.‎

Sincere thanks also extend to the secretaries: Samar Hussein and Eman Ragab, as well as the editor: Mohamed Salah.

- Acronyms and Abbreviations

ABR           Auditory brainstem responses

BIH            Benign intracranial hypertension

CBC          complete blood count

CBT           Cognitive Behavioral Therapy

CBT4T        Cognitive behavioral therapy for tinnitus

CPG          Clinical Practice Guideline

CR®          co- ordinated reset

CT             Computed tomography

GRADE      Grading of Recommendations Assessment, Development and Evaluation

HADS        Hospital Anxiety and Depression Scale

MEGT        Multidisciplinary European Guideline for Tinnitus: Diagnostics, Assessment, and Treatment

MRI           Magnetic Resonance Imaging

RCTs          randomized controlled trials.

rTMS          Repetitive transcranial magnetic stimulation

tACS         Transcranial alternating current stimulation

tDCS         Transcranial direct current stimulation

TFI             Tinnitus Functional Index

THI            Tinnitus Handicap Inventory

THQ           Tinnitus Handicap Questionnaire

TMJ           Temporomandibular joint

TQ             Tinnitus Questionnaire

TRQ           Tinnitus Reaction Questionnaire

TRT            Tinnitus Retraining Therapy

TSI             Tinnitus Severity Index

TSQ           Tinnitus Severity Questionnaire

VEMP        vestibular evoked myogenic potential

vHIT          Video Head Impulse Test

- Glossary

Definitions:

▪️ Tinnitus: Tinnitus involves the percept of a sound or sounds in the ear or head without an external source.

▪️ Pulsatile tinnitus: a sound in the ear or head without an external source, that is perceived as pulses. It is either vascular (synchronous with the heartbeat) and non-vascular. Vascular causes can be subcategorized into arterial or venous.

▪️ Subjective Tinnitus: Tinnitus heard by the patient only.

▪️ Objective Tinnitus: Tinnitus heard by the patient and the examiner.

▪️ Acute Tinnitus: Tinnitus of < 3 months duration.

▪️ Sub-acute Tinnitus: Tinnitus from 3-6 months duration.

▪️ Chronic Tinnitus: Tinnitus of >6months duration.

▪️ Habituation: a decreased response to a stimulus on repetitive stimulation.

▪️ Hyperacusis: oversensitivity to sounds, moderate level sounds perceived as loud, sounds others perceive as normal seem uncomfortably — and often unbearably loud. It’s also described as decreased sound tolerance or intolerance to loud sounds.

- Executive Summary

- Introduction, scope and audience

- Methods

➡️ Methods of development

Stakeholder Involvement: Individuals who were involved in the development process. included the above-mentioned Audiology Chief Manager, Audiology Executive Manager, Assembly Board, Grading Board and Reviewing Board

Information about target population experiences, views and preferences were not applicable for this topic.

➡️Search method

Electronic database searched:‎

Pubmed, Medline, Egyptian Knowledge Bank, Medscape, WebMD, Google Scholar

➡️Keywords:‎ 

The adaptation cycle passed over: set-up phase, adaptation phase (Search and screen, assessment: ‎currency, content, quality & /decision/selection) and finalization phase that included revision and external ‎reviewing. ‎ We used modified adapt process that consisted of three main phases, including planning and set-up, adaptation, and development of a final product.

➡️Time periods searched: from January 2010 to March 2020).

➡️Results

Three audio-vestibular medicine experts assessed the six tinnitus guidelines, where the multidisciplinary European guideline for tinnitus: diagnostics, assessment, and treatment, 2019 [2], gained the highest scores as regards the currency, contents, and quality (Annex 2:  tables 1-3 [3]).

It was graded by 20 expert audio-vestibular medicine consultants and reviewed by 3 expert audio-vestibular medicine physicians reviewers, and 1 neurologist reviewer and 1 psychiatrist reviewer and 2 radiologists physicians reviewers, to improve quality, gather feedback on draft recommendations. The external review was done through a rating scale as well as open-ended questions.

➡️Intended Users of the guideline: ENT and Audio-Vestibular Medicine Physicians, to be used to make and inform clinical decisions regarding management of older children and adults with subjective tinnitus and/or appropriate referral.

N.B. Levels of evidence: Quality of evidence for the treatment methods (treatment elements or protocols, devices, or procedures) was guided by the (GRADE Working Group, 2013). The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach to Decision frameworks (Table 1)

- Recommendations

The following statements and flowchart were adapted from the “Multidisciplinary European Guideline for Tinnitus: Diagnostics, Assessment, and Treatment, 2019” (MEGT) [2] which has the highest scores as regards the currency, contents, and quality.

Recommendations statements

Clinical questions	Action Recommendation	Level of Evidence (High, moderate, low, very low)	Strength of recommendation After Adaptation by Egyptian AVM: (Strong, conditional	Study Type	Reference
1. Diagnostics, assessments, and outcomes:
1.a. Minimum patient assessment (It is crucial to perform a detailed history/ clinical examination)	There are causal diagnostics and severity-oriented diagnostics: I.  A comprehensive patient history: 1) Tinnitus history. 2)  Thorough audiological history and complaint prioritization. 3) Medical history. 4) Presence of comorbidities/drug history/medications. 5) Relevant personal history, occupational history, hobbies/ leisure activities, noise exposure, head/ neck trauma, social support status, education, recent life events.	Very Low	Strong Recommendation for	Expert’s opinion	6
1.a. Minimum patient assessment (It is crucial to perform a detailed history/ clinical examination)	1) Tinnitus history: Tinnitus involves the percept of a sound or sounds in the ear or head without an external source. •  Onset, course, duration: Since when. sudden or gradually with a continuous increase? It can be acute < 3 months, sub-acute (3-6 months) or chronic (>6months) duration. Important associated clinical factors (noise trauma, stress, recent events, acute illness, other). •  Unilateral or bilateral? •  Character? • Modulation? (Helps to differentiate causes of objective tinnitus which can be pulsatile or non-pulsatile (Somatosensory tinnitus [respiratory, articular]). N.B. Pulsatile tinnitus follows a person’s heartbeat and can be either subjective or objective. It is commonly associated with venous and arterial abnormalities. Pulsatile tinnitus can be discriminated as venous or arterial, based on whether it disappears with pressure in the jugular vein or not). The overall approach and assessment of patients with pulsatile tinnitus differs from that for patients with subjective tinnitus, and special clinical investigations should be implemented because serious and potentially reversible causes might be found. N.B. Somatosensory tinnitus is considered when it can be modulated by somatic stimulation or movement. Modulation by: Orofacial, cervical or eye movements? Head positions? Movements of the jaw, tension of jaw muscles? Physical exertions? breathing? In some cases, pulsatile tinnitus can be modulated by movement of the head or upper lateral neck. • Severity/impact of the tinnitus: the degree established by a questionnaire • Is the tinnitus bothersome/ interfering with daily life (sleep difficulties, task interruptions, fearful reactions, cognitive-attentional problems, negative affect)? A questionnaire should be used to establish the degree to which a patient experiences subjective tinnitus as bothersome or distressing (see Sect. 1.d. for more details). •  The level of tinnitus awareness: - perceived only in silence or also in noise? - easily masked or amplified by ordinary background noise? - changes in tinnitus loudness?	Very Low	Strong Recommendation for	Expert’s opinion	6
1.a. Minimum patient assessment (It is crucial to perform a detailed history/ clinical examination)	2) Thorough audiological history and analysis of the complaint and complaint prioritization: ▪️ “Ear fullness”, or ▪️ Hyperacusis. ▪️ problems in balance/ dizziness/vertigo	Very Low	Strong Recommendation for	Expert’s opinion	6
1.a. Minimum patient assessment (It is crucial to perform a detailed history/ clinical examination)	3)  Medical history: • ear, nose and throat, •  orthopaedic, •  cervical, •  dental, jaw, •  internal medicine, •  mental disorders (psychological, psychiatric).	Very Low	Strong Recommendation for	Expert’s opinion	6
1.a. Minimum patient assessment (It is crucial to perform a detailed history/ clinical examination)	4)  Presence of comorbidities/drug history/ medications; ototoxic drugs; long-term pharmacological consumption (e. g. antidepressants, anxiolytics)	Very Low	Strong Recommendation for	Expert’s opinion	6
1.a. Minimum patient assessment (It is crucial to perform a detailed history/ clinical examination)	5) Relevant personal history, occupational history, hobbies/leisure activities, noise exposure, head/ neck trauma, social support status, education, recent life events	Very Low	Strong Recommendation for	Expert’s opinion	6
1.a. Minimum patient as- sessment (It is crucial to per- form a detailed history/ clinical examination)	II- Conduct a thorough physical–medical assessment to exclude possible treatable (physical/medical) causes of tinnitus: ◾Complete ear, nose, and throat examination, • especially Otoscopy (preferably micro-otoscopy) to exclude presence of wax, tympanic membrane rupture, otitis media with effusion, chronic otitis media, or any other pathology. In Otoscopy: Special attention to retro-tympanic mass, Schwartz sign, in addition to other clinical examination for pulsatile tinnitus: • Ask the patient to tick his/her finger in each pulse, while taking radial pulse • Press jugular vein and ask patient whether tinnitus is alternated • Use a stethoscope for auscultation of the ear (mastoid, external auditory meatus) and carotid artery (neck), and chest in pulsatile tinnitus, as clinically indicated. Special consideration should be given in rare tinnitus causes (e. g. palatal myoclonus, temporomandibular joint [TMJ] disorders). • A comprehensive diagnostic investigation: • Pure tone audiometry, • Speech audiometry, •  Evaluation of the perceptional quality of tinnitus (e.g., Loudness, pitch, and minimum masking estimations), •  Sound tolerance assessment by Loudness Discomfort Level for tones, to be used for sound sensitivity grading or hearing aid settings. • Tympanometry and acoustic reflex N.B. Care must be taken in performing any of the previous loud- ness-based diagnostic investigations, particularly where there is evidence of recent fluctuations in loudness or intensity of the patient’s tinnitus or reduced sound tolerance.	Very Low	Strong Recommendation for	Expert’s opinion	6
1.b. Further assessment	III- Further investigations or referrals in special cases. Only to be considered if clinically indicated: ◾Auditory brainstem responses (ABR) and/or magnetic res- onance imaging (MRI). ◾ High-frequency audiometry in cases of tinnitus with normal hearing at standard (conversational) frequencies. ◾Further Radiological evaluation for pulsatile tinnitus [7, 8, 9]: ü Arterial pulsatile tinnitus:  Carotid triplex (stenosis) •  Computed tomography angiography (glomus, aneurysms, atherosclerosis, arteriovenous malformations) ü Venous pulsatile tinnitus: •  Magnetic resonance angiography (arteriovenous malformations, empty sella syndrome, Arnold–Chiari malformation, Sylvius aqueduct stenosis, sigmoid sinus diverticulosis, etc.). • N.B. high-resolution, temporal bone CT in case of retrotympanic mass (glomus tympanicum, aberrant internal carotid artery, or jugular bulb abnormalities) if diagnosed, no other imaging stud- ies are needed [9]. • When imaging is normal, consider benign intracranial hypertension (BIH), especially in patients with a high body mass index. Further investigations or referrals in special cases. Only to be considered if clinically indicated: •  Residual inhibition to evaluate short-term effects of sound on the tinnitus •  Transient-evoked otoacoustic emissions and/or distortion product otoacoustic emissions in cases of normal standard audiogram and suspicion of cochlear dysfunction •  Vestibular investigations: e.g., videonystagmography (VNG), video head impulse test (vHIT), and vestibular evoked myogenic potential (VEMP), as indicated in cases of dizziness, vertigo, or balance problems •  Functional cervical diagnostics in a quiet environment for detecting tinnitus modulations in somatosensory tinnitus. Consider imaging of cervical spine in cervical pathology associated with somatosensory tinnitus. •  Dental examination (including temporomandibular joint (TMJ)) in a quiet environment for detecting tinnitus modulations in TMJ dysfunction or bruxism •  Laboratory investigations, [e.g., complete blood count (CBC): for hyperdynamic circulation (anemia, etc..) …etc..] •  Fundus examination: for Benign intracranial hypertension (BIH) MRI of the brain in abnormal auditory brainstem response or abnormal vestibular evoked myogenic potential.	Very Low	Strong Recommendation for	Expert’s opinion	6, 7, 8, 9
1.c. Red Flags that need urgent referral for Assessment/ Management	1. Unilateral tinnitus 2. Tinnitus in association with asymmetric or unilateral sensorineural hearing loss 3. Pulsatile tinnitus 4. Tinnitus in association with significant acute vertigo 5. Tinnitus secondary to head trauma 6. Tinnitus in association with significant neurological symptoms and/or signs 7. Tinnitus causing psychological distress.	Very Low	Strong Recommendation for	Expert’s opinion	1
1.d. Assessment by questionnaires	Tinnitus severity in terms of distress/impact: Tinnitus patients who report complaints/ show decompensation (grade 2 and higher: (refer to the flowchart) should be evaluated with a measure of tinnitus-related disability, such as: ◾The Tinnitus Handicap Inventory (THI) questionnaire) (Newman et al., 1996) [10] ◾The Tinnitus Questionnaire (TQ) (Hallam, 1996) [11] ◾ The Tinnitus Reaction Questionnaire (TRQ) (Wilson et al., 1991) [12] ◾ The Tinnitus Severity Index (TSI) (Meikle et al, 1995) [13]. ◾The Tinnitus Handicap Questionnaire (THQ) (Kuk et al.,1990) [14] ◾The Tinnitus Severity Questionnaire (TSQ) (Coles et al., 1991) [15 ◾The Tinnitus Functional Index (TFI) questionnaire (Meikle et al, 2012) [16] The TQ and the THI are widely used in clinical practice and clinical trials. Additionally, almost all existing clinical practice guidelines recommend using the Hospital Anxiety and Depression Scale (HADS) [17] to assess negative affect coinciding with or reactionary to tinnitus. N.B. There are available tinnitus questionnaires in Arabic language to be used by Egyptians: Arabic translation of the already present Tinnitus questionnaires and newly developed and validated Arabic Tinnitus questionnaires: Arabic translation of the THI [18, 19], TRQ [20], TFI [21] Arabic translation of HADS [22], Tinnitus Primary Function Questionnaire (TPFQ) (Tyler et al., 2014) [23] Arabic translation [24]. Available Newly Developed Arabic Tinnitus questionnaires, Arabic Tinnitus Reaction Questionnaire [25], Arabic Tinnitus Cognition Questionnaire [26], Arabic self-assessment Tinnitus distress scale [27]	Very Low	Strong Recommendation for	Expert’s opinion	6

 

Clinical questions	Action Recommendation	Level of Evidence (High, moderate, low, very low)	Strength of recommendation After Adaptation by Egyptian AVM: (Strong, conditional	Study Type	Reference
Treatment options and referral pathways. Available treatments and evidence:
2. a. Drug/ pharmacological	Treatment of acute tinnitus is given according to treatment of acute sudden hearing loss. But, if tinnitus occurs acutely without hearing loss, the standard cortisone therapy is not recommended. Therapeutic approaches such as intratympanic steroid treatment have no effect on tinnitus. Any increase in tinnitus severity or distress in chronic tinnitus should not be treated as new onset tinnitus but should be regarded and treated as a fluctuation of chronic tinnitus.	Very Low	Strong Recommendation Against (acute tinnitus), but Strong Recommendation for (acute sudden hearing loss)	Expert’s opinion	28
	For chronic tinnitus, many classes of drugs have been used or trialed, including various antiarrhythmics, anticonvulsants, anxiolytics, glutamate receptor antagonists, antidepressants, muscle relaxants, and others, with little evidence of benefit over harm.   There is no evidence for the effectiveness of drug treatments specifically for tinnitus but evidence for potentially significant side effects. Recommendation is based on systematic reviews and randomized trials. No drug can generally be recommended for the treatment of chronic tinnitus. However, psychiatric comorbidities associated with tinnitus (anxiety, depression) may need drug treatment. Antidepressants should not be prescribed to tinnitus patients without the diagnosis of depression.	High	Strong Recommendation Against (chronic tinnitus), but Conditional Recommendation for (associated comorbidities)	Systematic Reviews	6, 29, 30
2. b. Hearing loss interventions   2. b.i. Cochlear implants.	Cochlear implantation is recommended only for patients meeting the hearing loss criteria for candidacy. Recommendation for tinnitus based on evidence for safety but low-level evidence of effectiveness.  Also, a recent systematic review (Assouly et al., 2021) [32], where patients in the included studies had tinnitus as a primary complaint, i.e., all had asymmetrical hearing loss or single-sided deafness, revealed that electrical stimulation by cochlear implants in patients with a primary complaint of tinnitus has a positive impact on tinnitus distress. Nevertheless, only small sample sizes were found, and studies showed considerable risks of bias.	High	Strong Recommendation Against (tinnitus), but Strong Recommendation for (deafness)	Systematic Reviews	6, 31, 32
2. b. Hearing loss interventions   2. b. ii. Hearing aids.	• Hearing aids are recommended for the management of hearing loss and should be considered as an option for patients with tinnitus and hearing loss. Recommendation is based on evidence of effectiveness and safety in RCTs of hearing aids for hearing loss and tinnitus, and systematic reviews considering hearing aids for tinnitus. •  Hearing aids should not be offered to tinnitus patients without hearing loss. Tinnitus might be a parameter to be considered in hearing aid fitting and consequent relevant decision-making.	High	Conditional Recommendation for	Systematic Reviews, RCTs	33-38
	•  Combination hearing aids (including amplification and sound generator in the same device) are another option for patients who may benefit from both amplification and passive sound stimulation.   Hearing aids are found to be equally beneficial to combination hearing aids for tinnitus with hearing loss.	High	Conditional Recommendation for	RCT	39
2.c.Neurostimulation: 2.c. i. Transcranial electrical stimulation. • 2.c. ia. Transcranial direct current stimulation (tDCS) 2.c. ib. Transcranial alternating current stimulation (tACS)	There is evidence for safety but no evidence for the effectiveness of transcranial electrical stimulation for tinnitus. Recommendation is based on systematic review and RCTs.	High	Strong Recommendation Against	Systematic Review, RCTs	40-45
2.c. ii. Transcranial Vagus nerve stimulation.	Paired with sound stimuli (to promote reorganization in the auditory Cortex: There is evidence for safety but insufficient evidence that vagus nerve stimulation treatments have effects on tinnitus. Recommendation is based on the lack of RCTs or systematic review.	moderate	Conditional Recommendation Against	RC pilot study	46
2.c. iii. Repetitive transcranial magnetic stimulation (rTMS)	A recent study (Galal et al., 2020) [47] included five randomized controlled double-blind trials in this systematic review investigating the efficacy of rTMS for at least six months post treatment, one followed up monthly for 10 months. TMS reduced the THI score and decreased the severity of tinnitus in 45% of patients and lead to a complete recovery in 32% of cases in one study. However, the meta-analysis demonstrated lack of significant effect of TMS on tinnitus management. An updated meta-analysis (Yin et al, 2021) [48] demonstrated that rTMS improved tinnitus-related symptoms, in terms of the short-term and long-term effects (6 months) on the THI scores, but the TQ and BDI scores demonstrated little immediate benefit. Future research on large samples in multi-centre settings with longer follow-up durations was recommended.	High	Conditional Recommendation for	Systematic Reviews, meta-analysis	47, 48
2.c.iv. Acoustic co- ordinated reset (CR®) neuromodulation.	Acoustic CR® neuromodulation is a sound therapy involving a randomized sequence of four “phase resetting” tones adjusted to the patient’s dominant tinnitus pitch that are hypothesized to generate a lasting desynchronization of the pathological brain	High	Conditional Recommendation for	Systematic review	49
2. c.v. Invasive neurostimulation treatments:   2. c.v.i. Direct (i. e. implanted electrode) Vagus nerve stimulation, paired with acoustic stimulation for tinnitus   chronic electrical vestibulocochlear nerve stimulation   2. c.v.ii. Cortical surface stimulation brain surface (extradural) implanted electrodes,   2.c.v.iii. Deep brain neural stimulator implantation.	There is no high-level evidence for the effectiveness or safety of invasive treatments for tinnitus. Recommendation is based on lack of RCTs or systematic review.	very low	Conditional Recommendation against	a scoping review	50
2.d. Cognitive Behavioural Therapy (CBT)	Cognitive behavioural therapy for tinnitus (CBT4T) to modify dysfunctional behaviours and beliefs. It often includes a combination of several elements (such as education, counselling, exposure, mindfulness, relaxation, hearing rehabilitation). Stepped-care multimodal CBT4T approach in which: audiological diagnostics, treatment and consultation as well as CBT-treatment elements are combined. ◾ Face-to-face CBT treatment ◾ CBT in a self-help format (internet-based or otherwise). CBT should be guided and monitored by specialized doctors i.e., psychiatrists. There is high-level evidence for the effectiveness and safety of CBT for tinnitus. Recommendation is based on systematic review and one further RCT.	High	Strong Recommendation for	Systematic Review, RCT	51, 52
2.e. Tinnitus Retraining Therapy (TRT)	Based on the neurophysiological model of tinnitus. It utilizes directive counselling to decrease the negative tinnitus-evoked reactions and sound to decrease the strength of tinnitus signal. The principal goal of TRT is to achieve habituation of tinnitus through the re- training of the brain. Based on a medical evaluation of tinnitus, patients are placed into one of five general categories, each with a specific variant of TRT treatment, and all patients receive counselling and sound therapy, with substantial differences. Sound therapy acts by providing the auditory systems with constant neutral signs with sound generators, hearing aids, or background noise. There is evidence for safety but little high-level evidence for the effectiveness of TRT. Based on availability of a recent meta-analyses and systematic review (Han et al., 2021) [53], analysis of limited studies low-quality evidence with a high risk of bias showed that the TRT was an effective treatment for tinnitus, which could improve the response rate of tinnitus and reduce the THI scale.	High	Conditional Recommendation for	meta-analyses and systematic review	38, 53
2.f. Sound therapy	There is evidence for safety but little high-level evidence for the effectiveness of sound therapy. Recommendation is based on RCTs and a systematic review. Sound therapy (including masking, music, environmental sound) may be useful for acute relief purposes but is not considered an effective intervention with long-term results. • Acoustic stimulation might improve tinnitus through some interaction with tinnitus mechanisms, through the partial or complete masking of tinnitus, and/or through certain cognitive influences (diversion, stress management etc.). • Sound therapy is used in different ways, and includes: ◾Tinnitus masking therapy. ◾ Neuromonics approach. consists of an acoustic stimulation combining music and broadband noise and counselling. The spectrum of this combination is customized to provide an equalized stimulation over the audible frequency range and provide stimulation within the deprived sensory region, and to promote relaxation and relief. ◾Notched music stimulation. the notch (1 octave width) being chosen to correspond to the tinnitus pitch. This approach is thought to reverse the “maladaptive cortical reorganization”. Customized music stimulation. aimed at reversing the tinnitus-related central changes due to hearing deprivation	High	Conditional Recommendation for	RCTs Systematic Review	54-60
2.g. Dietary and alternative therapies	There is evidence that dietary and alternative therapies have no proven efficacy and pose potential harm in the management of tinnitus. Recommendation is based on RCTs and systematic reviews with methodological concerns. Dietary and alternative therapies (e.g. ◾Ginkgo biloba. herbal supplement ◾Melatonin: a hormone secreted by the pineal gland that is involved with regulation of the sleep– wake cycle. ◾Dietary supplements. •  Zinc, •  lipoflavonoids, •  garlic, •   homeopathy, •  traditional Chinese/Korean herbal medicine, •  honeybee larvae, and Other various vitamins and minerals.	High	Strong Recommendation Against	Systematic Review,	61-66
2.h. Acupuncture.	There is evidence for safety but little high-level evidence for the effectiveness of acupuncture. Recommendation is based on systematic review	High	Conditional Recommendation Against	Systematic Review, RCTs	67
3. Patient information and support.	•   It is essential to successful tinnitus treatment that patients are provided with reliable information and learning resources. •  The provision of information should be timely and fill gaps in knowledge, dispel myths, offer hope, and provide key messages that are a framework for treatment. • Information should never be negative. In the assessment, information is gathered about how tinnitus is affecting the patient in their daily life, about their understanding of tinnitus, and their concerns or fears surrounding it. This can be used to explore with them how their beliefs about tinnitus and the meaning they attach to it influences how they think, feel, and react to it. Health-care professionals should be compassionate to the concerns and fears expressed by patients.	High	Strong Recommendation for	Cochrane Review	68
	→       Patient information and support topics should be tailored to the patient’s need and what is available to them. Topics include: ◾What is tinnitus? ◾What causes and maintains it? ◾Pulsatile tinnitus (follows heartbeat) ◾Common misunderstandings and Myths ◾Hearing loss and hearing aids ◾Ear wax removal ◾Hyperacusis and tinnitus ◾Protecting your hearing ◾Habituating to tinnitus ◾Relaxation ◾Monitoring tinnitus ◾Use of sound ◾Dealing with sleep problems ◾ Dealing with emotional consequences of tinnitus ◾Self-help and support groups
4- Measuring The  Tinnitus Treatment Outcome	Measuring improvement: by finding a change from a degree of severity to less degree of severity after an intervention, using the same questionnaire before and after the intervention, or by finding a minimum clinically significant change in a before- after treatment score (a meaningful response criterion) by using the THI or TFI Questionnaires: ◾7-point reduction in THI (Newman et al., 1996) [10], even if no change in tinnitus degree of severity. ◾ 13-point reduction in TFI (Meikle et al., 2012) [16], even if no change in tinnitus degree of severity. N.B. Arabic language tinnitus questionnaires are available for use by the Egyptians [18-27].	High	Strong Recommendation for	Systematic Review	6, 69, 70

- Research needs

Research questions.

There is a need to conduct randomized controlled trials (RCTs) to determine the efficacy of Sound therapy.

There is a need to conduct RCTs to determine the efficacy of Neuromodulation.

There is a need to conduct RCTs to determine the efficacy of Combining therapies.

There is a need to determine the efficacy and safety of different management strategies for tinnitus and hyperacusis in children.

- Monitoring and evaluating the impact of the guideline

Monitoring/ Auditing Criteria: to assess guideline implementation or adherence to recommendations.

▪️ Performing a targeted history and thorough Basic Audiological Evaluation as a minimum patient assessment, with further audio-vestibular investigations only if indicated, and urgent referral of any tinnitus Red Flags.

▪️ Providing information about tinnitus and treatment options.

▪️ Prescribing hearing aids only when patients have a diagnosed hearing loss.

▪️ Specialized cognitive behavioral therapy for tinnitus should be offered when needed.

- Updating of the guideline

Updating Procedure:‎

- References

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36. Hoare DJ, Edmondson-Jones M, Sereda M, Akeroyd MA, Hall D (2014) Amplification with hearing aids for patients with tinnitus and co-existing hearing loss. Cochrane Libr2014(1):CD010151

37. Nguyen MF, Bonnefoy M, Adrait A, Gueugnon M, Petitot C, Collet L, Perrot X et al (2017) Efficacy of hearing aids on the cognitive status of patients with Alzheimer’s disease and hearing loss: A multicenter controlled randomized trial. J Alzheimers Dis 58(1):123–137

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43. Shekhawat GS, Searchfield GD, Stinear CM (2014) Randomized trial of transcranial direct current stimulation and hearing aids for tinnitus management. Neuro rehabil Neural Repair 28(5):410–419

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52.  Cima RFF, Andersson G, Schmidt CJ, Henry JA (2014) Cognitive-behavioral treatments or Tinnitus: a review of the literature. J Am Acad Audiol 25(1):29–61

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73.  Association of the Scientific Medical Societies (2015).  German S3 Guideline 01A/064: Chronic Tinnitus [AWMF-Register Nr. 01A/064 Klasse: S3 Chronischer Tinnitus]. AWMF online. https://www.awmf.org/fileadmin/user_upload/Leitlinien/01A_D_G_f_Hals-Nasen-Ohrenheilkunde__Kopf-_und_Halschirurgie/01A-064e_S3_guideline_tinnitus_english_2015-08.pdf

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75. Tinnitus: NICE National Institute for Health and Care Excellence guideline. Publication date: 11 March 2020, https://www.nice.org.uk/guidance/ng155

- Annexes

Editorial Independence:‎

▪️ This guideline was developed without any external funding.‎

Annex 1: Guideline Flowchart

Annex 2: Tables of appraisal of selected guidelines: currency (table 1), content (table 2), and quality (table 3), of the selected guidelines {2, 71, 72, 73, 74, 75], according to the Practice guidelines evaluation and adaptation cycle [3].
 

Table 1. Guidelines Currency:

Table 2. Assessment of Content:

Table 3. Assessment of Quality (CPG Appraisal tool):

Annex 3: The benefits and harms of all added, modified statements, N.B. No omitted statements 

Consideration Of Benefits and Harms that were considered when formulating the recommendations are shown in the following tables (4 & 5):

Table 4: Original and adapted Summary of CPG recommendations of the selected guideline:

Table 5: Summary of Added CPG recommendations for the selected guideline: