RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1. NAME OF THE CANDIDATE AND ADDRESS Dr. Sineesh P. Joy Post Graduate Student Department of Community Health St. John’s Medical College Sarjapur Road Bangalore-560 034

2. NAME OF THE INSTITUTION St. John’s Medical College, Bangalore

3. COURSE OF THE STUDY AND SUBJECT MD - Community Medicine

4. DATE OF ADMISSION TO THE COURSE 1st June, 2013

5. TITLE OF THE TOPIC Effectiveness of Audiological Rehabilitation using Hearing Aid among the beneficiaries of a Rehabilitation Programme in Rural Karnataka

6. BRIEF RESUME OF THE INTENDED WORK

6.1 Introduction Hearing is a fundamental sense in life, it is the very basis of human communication. Hearing loss causes not only a handicap in the person’s capacity to perceive sounds, it brings about psychosocial compromises, keeping the individual from having a healthy social life and playing his/her role in society, which has a great impact on the person’s quality of life1. Hearing loss is the most prevalent sensory disability and a problem that is increasing globally2. More than 275 million people are reported to have moderate to profound hearing loss 2. Hearing aids have a remarkable effect on the hearing related quality of life and communication skills3. Mulrow et al. reported improvements in social and emotional functioning, communication, cognitive ability, and even depression in a study in which patients who received hearing aids were compared to those who were assigned to a waiting list.4 In the same study, it was also observed that the average self-reported hearing aid use was 8 hours a day4. In a one year follow-up of these hearing aid users it was seen that the quality-of-life dimensions showed significant improvement, except for cognitive ability, which had reverted to baseline5.

6.2 Need for the study The goal of speech and hearing therapists who fit hearing aid is to satisfy the user, guarantee better communication possibilities thereby contributing to the improved patient’s quality of life. However, one of the greatest difficulties faced by these professionals is how to validate the success obtained from using such devices1.

Despite all the advantages technological progresses may bring about, it is mandatory to understand the real hearing difficulties of the users and their expectations as to the amplification, so as to better the individualized clinical care.6 The performance with the hearing aid reported by the user can better guide the healthcare professionals to take proper actions, enabling one to recognize the advantages provided by these devices in relation to hearing difficulties, increasing daily use, preventing users to give up on them, consequently, user satisfaction. Therefore, in order to obtain better patient satisfaction, the user’s opinion is certainly one of the most important factors.1

The Department Of Community Health, St. John’s Medical College, Bangalore initiated a project Asha Dhwani in the year 1999 to identify persons with hearing impairment and ear diseases in rural Karnataka so as to provide community based primary ear care. Through this project hearing aids are provided at a low cost to people with hearing impairment based on audiometric assessment. The patients are allowed a two week hearing aid trial after which the hearing aid is given to them. There is no published research on the assessment of effectiveness of the audiological rehabilitation among beneficiaries of this project till date.

6.3 Review of literature

6.3a Definition of hearing impairment Hearing impaired individuals include those who are hard of hearing and those who are deaf. Hard of hearing refers to a partial hearing loss which results in difficulty in speech comprehension, although some auditory function remains. Deaf refers to a degree of impairment that renders hearing nonfunctional for ordinary purposes of life.7 The World Health Organization (WHO) defines disabling hearing impairment in adults as a permanent unaided hearing threshold level (average for frequencies 0.5, 1, 2, 4 kHz) for the better ear of 41 dB or greater (WHO, 2001) 8. In children under 15 years of age, disabling hearing impairment is defined as permanent unaided hearing threshold level (average for frequencies 0.5, 1, 2, 4 kHz) for the better ear of 31 dB or greater8.

6.3b Types of hearing impairment.8 There are 3 types of hearing impairment according to the site where problem occurs: 1. Conductive hearing impairment: This is a problem in the external or middle ear which is often medically or surgically treatable. 2. Sensorineural hearing impairment: This is usually due to a problem with the internal ear and occasionally due to a problem with the vestibulocochlear nerve. This type of hearing impairment is usually permanent and requires rehabilitation such as with a hearing aid. 3. Mixed impairment: This is caused by a combination of conductive damage in the outer or middle ear and sensorineural damage in the inner ear (cochlea) or hearing/auditory nerve.

6.3c Common Causes of hearing impairment.8 The causes of conductive hearing impairment are obstruction in the ear canal, congenital meatal atresia, tympanic membrane perforation, serous otits media, cholesteatoma, and otosclerosis. The causes of sensorineural hearing impairment are intrauterine infections (like rubella and syphilis), presbycusis, ototoxic drugs(e.g., gentamycin) ,infections or trauma to labyrinth or 8th nerve, noise induced hearing loss, acoustic neuroma.8

6.3d Prevalence of hearing impairment Hearing loss is one of the most prevalent sensory disabilities and a problem that is increasing globally. More than 275 million people are reported to have moderate to profound hearing loss 2.WHO estimates approximately 63 million people are suffering from significant auditory impairment in India; this places the estimated prevalence at 6.3% in Indian population9. As per the National Sample Survey Organization (NSSO), currently there are 291 persons per one lakh population suffering from severe to profound hearing loss (NSSO, 2001)9. The large burden of people with hearing impairment in India is amounting to severe loss in productivity, both physical and economic.9

6.3e Impact of hearing loss i. Functional Impact One of the main functional impacts of hearing loss is on the individual’s ability to communicate with others. Spoken language development in severely or profoundly deaf children of hearing parents is typically delayed compared with that of their hearing counterparts. 10-11 Hearing loss and ear diseases such as otitis media have a significantly adverse effect on the academic performance of children. Hearing loss in schoolchildren is reported to be linked to a variety of academic and adjustment problems. Children with hearing loss are sometimes considered to have lower IQs than their hearing counterparts, which may lead to rejection from schools; research has shown this presumption to be incorrect. Early detection and intervention are the most important factors in minimizing the impact of hearing loss on a child’s development. Early identification of any level of hearing loss, coupled with appropriate management, has been clearly shown to lead to significant improvement in a child’s social and educational achievements.12-14 ii. Economic Impact According to a 2007 World Bank report unemployment rates in India are much higher than normal among people living with disabilities, including hearing loss. Recent data also show that a greater proportion of the deaf and hard of hearing population is unemployed compared with the hearing population. Moreover, among those who are employed, a higher percentage of people with hearing loss are in the lower grades of employment. In addition to its effects on the individual, hearing loss has a substantial impact on social and economic development at community and country levels.15-16 iii. Social and emotional Impact For elderly people, impaired communication due to hearing loss can have a significant impact on everyday life, resulting in feelings of loneliness, isolation, frustration and dependence. This is rarely appreciated by people with normal hearing, who equate slowness in understanding the spoken word with mental inadequacy. As a consequence, older individuals may withdraw further, often remaining aloof in order to avoid being labeled as “slow” or “mentally inadequate”.17

6.3f What are hearing aids18 Hearing aids are sound-amplifying devices designed to aid people who have a hearing impairment. Most hearing aids share several similar electronic components, including a microphone that picks up sound; amplifier circuitry that makes the sound louder; a miniature loudspeaker (receiver) that delivers the amplified sound into the ear canal; and batteries that power the electronic parts. Hearing aids differ by: a. Design b. Technology used to achieve amplification (i.e., analog vs. digital) c. Special features Some hearing aids also have ear moulds or earpieces to direct the flow of sound into the ear and enhance sound quality. The selection of hearing aids is based on the type and severity of hearing loss, listening needs, and lifestyle.

By design,  Body worn type: All parts except receiver are in a case, worn at the chest level while receiver at the ear level.  Behind-the-ear (BTE) aids: Most parts are contained in a small plastic case that rests behind the ear.  In-the-ear (ITE) aids: All parts of the hearing aid are contained in a shell that fills in the outer part of the ear.  Canal types(in the canal and completely in the canal types): So small that the entire ear aid can be worn within the ear canal

6.3g Difference between analog and digital hearing aids18 Analog hearing aids make continuous sound waves louder. These hearing aids essentially amplify all sounds (e.g., speech and noise) in the same way. Some analog hearing aids are programmable. They have a microchip which allows the aid to have settings programmed for different listening environments, such as in a quiet place, like at a library, or in a noisy place like in a restaurant, or in a large area like a soccer field. The analog programmable hearing aids can store multiple programs for the various environments. As the listening environment changes, hearing aid settings may be changed by pushing a button on the hearing aid. Analog hearing aids are becoming less and less common. Digital hearing aids have all the features of analog programmable aids, but they convert sound waves into digital signals and produce an exact duplication of sound. Computer chips in digital hearing aids analyze speech and other environmental sounds. The digital hearing aids allow for more complex processing of sound during the amplification process which may improve their performance in certain situations (for example, background noise and whistle reduction). They also have greater flexibility in hearing aid programming so that the sound they transmit can be matched to the needs for a specific pattern of hearing loss. Digital hearing aids also provide multiple program memories. Most individuals who seek hearing help are offered a choice of only digital technology these days.18 6.3h Usage of hearing aid Technical advances in hearing aid technology are improving hearing aid compliance. Vuorialho et al. described a marked improvement in hearing aid use in their interview study, compared to a study that took place 20 years previously and used the same methods. The percentage of regular users was increased from 40.9% to 56.6%; more importantly, the proportion of nonusers diminished from 33.3% to 5.3%.19

6.3i Satisfaction with the hearing aid A study in US shows that customer satisfaction to hearing aid is slowly increasing20. It showed that the overall satisfaction with hearing aid increased by 6% to 74% from 2004 to 2008. The factors that are most correlated with overall hearing aid satisfaction were: Overall benefit, Clarity of sound, Value (performance of the hearing aid relative to price), Natural sounding, Reliability of the hearing aid, Richness or fidelity of sound, Use in noisy situations, Ability to hear in small groups.

According to a study by Sergei Kochkin, 55% is the average benefit (hearing handicap improvement) achieved by patients with recent hearing aid technology, 75% of patients reported at least one area of their life being improved by wearing hearing aids21. 80% of hearing aid users were satisfied with the changes that have occurred in their lives due to hearing aids, 90% of patients were projected to experience significant improvements in their quality of life once they experience a 70% reduction in their hearing handicap.21

A study in Brazil shows that the participants were very happy with their hearing aid. The study also showed that the satisfaction has no relationship with the variables like age, gender, time of use, and type of individual sound amplification device. In general, the subjects with the longer time of daily use are happier with their devices1.

In an analytical review of studies of hearing aid uptake and satisfaction, Knudsen et al. stated that a positive attitude towards rehabilitation and acceptance of hearing loss were favorable factors24. Age and gender did not have an effect on use and satisfaction; neither did educational level nor living arrangements (alone or with others). However, impaired dexterity appeared to reduce the daily use of a hearing aid.22

Parving and Philip used a questionnaire to study hearing aid use and its benefits in patients >90 years of age. Even in this age group, the benefit was clear. Among the respondents 50% used a hearing aid daily and 64% were satisfied with the hearing aid.23 A literature review done by Jenstad and Moon (2011) has given seven main factors influencing the hearing aid use. They include effect of the hearing loss on quality of life, stigma, degree of hearing loss, personality or psychosocial factors, cost of the hearing aid, age and gender.24

6.3j Impact of hearing aid on quality of life A study (by Mulrow et al 1990) involved a group of nearly 200 hearing impaired subjects aged 64 and over, showed that hearing aids can reverse social, emotional and communication dysfunctions caused by hearing impairment, and lead to improvements in cognition and mood.5

6.3k Tools used for assessment of usage and satisfaction Various self assessment scales have been used over many years. They include Hearing Measure Scale, Hearing Handicap Scale, Hearing Performance Inventory, Hearing Handicap Inventory for the Elderly, Hearing Aid Performance Inventory, Hearing Handicap Inventory for Adults, Profile of Hearing Aid Performance, Abbreviated Profile of Hearing Aid Benefit, Hearing Disability and Handicaps Scale, Hearing Attitude in Rehabilitation Questionnaire, Client Oriented Scale of Improvement, Glasgow Hearing Aid Benefit Profile(GHABP), Satisfaction with Amplification in Daily Life(SADL), Hearing Aid Needs Assessment , Hearing Aid Users Questionnaire(HAUQ) and International Outcome Inventory- Hearing Aid(IOI-HA).25

Systematic review of literature by Elvira Perez and Barrie A. Edmonds has revealed that GHABP and IOI-HA are the two popular tools used for assessing the hearing aid usage and customer satisfaction.26 The GHABP focuses very much on the situations important to the patient, but gives data that is difficult to compare against other studies and measures of usage. The IOI-HA is perhaps less patient needs focused, but gives data that is clearly comparable with other studies.26 IOI-HA is a seven-item inventory for outcome assessment not intended by the inventors to be a substitute for, but rather to supplement, other outcome schemes.28

I. GHABP27 uses six predefined subscales. 1. initial disability 2. handicap 3. hearing aid-use 4. hearing-aid benefit 5. residual disability and 6. satisfaction These subscales are addressed in four predefined and four optional user-nominated listening situations. They have been validated by using a paradigm in which sensitivity to alterations in audibility was the main factor determining the selection of predefined listening situations.27

II. IOI-HA28 measurement using a 5-point response in 7 domains as follows: 1. Use – indicates duration of daily use. 2. Improved activity – indicates how much the assistive technology has helped. 3. Residual activity limitation – indicates how much difficulty remains. 4. Satisfaction – indicates whether the assistive technology is worth the trouble. 5. Residual participation restrictions – indicates how much the hearing or moving difficulties have affected the things the user can do while using assistive technology. 6. Impact on others – indicates how much the user thinks others were bothered by his or her hearing or moving difficulties while using assistive technology. 7. Quality of life – indicates how much the assistive technology has changed the enjoyment of life. The response for each variable was transformed into a score within a range of 1–5, where higher scores signify more favourable outcomes.28

III. WHO Quality of Life BREF measures 4 domains of quality of life29 1. Psychological 2. Social relationship 3. Physical Health 4. Environment.29

6.4 OBJECTIVES

1. To assess the usage of hearing aid and the associated factors among the beneficiaries for the last 5 years of a hearing impairment project in rural area of Karnataka.

2. To estimate the level of satisfaction among the study population.

3. To evaluate the quality of life among the study population. 7. MATERIALS AND METHOD

7.1 SOURCE OF DATA Study Design: Descriptive Study Study Period: 1 year (January 2014 to December 2014) Study Site: Area under Domasandra, Lakkur, Sarjapur and Anugondanahalli Primary Health Centre Areas.

Sample size Sample size (n) is calculated by the formula n= (z² (pq))/ d² where, z = relative deviate (at 95% confidence interval) i.e. 1.96 p=estimated percentage of satisfied people q=1-p d=absolute precision The sample size is calculated based on the available estimated percentage of satisfied users22 74% with a confidence level of 95% and absolute precision of 10% Sample size is calculated to be 74.

Inclusion criteria: 1. The beneficiaries of the ASHA DHWANI project in the last 5 years (2008-2012) who are residing in the area under Domasandra, Lakkur, Sarjapur and Anugondanahalli Primary Health Centre Areas. Exclusion criteria: 1. Those who are seriously ill and not able to answer the questionnaire. 2. Those who are not able to comprehend. 3. Those who cannot be contacted after 3 visits. 7.2 METHOD OF DATA COLLECTION The details of the beneficiaries of the project including their age, sex, address, degree of hearing loss and the type of hearing aid received will be obtained from the records of the project. A house visit to the study population will be made for collection of data. A written informed consent will be obtained from the subject prior to interview. Following this, the subject identified is administered the questionnaire.

TOOLS: Part A: Socio-demographic details along with the details of type of hearing impairment and type of hearing aid. Part B: Glasgow Hearing Aid Benefit Profile (GHABP). Part C: International Outcome Inventory-Hearing Aid (IOI-HA). Part D: World Health Organization- Quality of Life BREF (WHOQOL-BREF).

7.3 ANALYSIS The data collected will be entered in Microsoft excel and analyzed using SPSS version 16. The demographic data will be initially analyzed using frequencies, mean, median and standard deviation. The data will be further analyzed under 3 subheadings: inter item co-relations, factor analysis and item total statistics.

7.4 Does your study require any investigations or interventions to be conducted on patients or other humans or animals? If so, please describe briefly No. 7.5 Has ethical clearance been obtained from your institution? Yes 8. LIST OF REFERENCES 1. Fernanda Soares Aurélio, Simone Pereira da Silva, Liliane Barbosa Rodrigues, Isabel Cristiane Kuniyoshi, Marília Silva e Nunes Botelho. Satisfaction of patients fit with a hearing aid in a high complexity clinic. Brazilian journal of Otorhinolaryngology. Sept./Oct.2012, 78(5).

2. WHO Library Cataloguing-in-Publication Data. Community-based rehabilitation: promoting ear and hearing care through CBR. http://www.who.int/pbd/deafness/news/CBREarHearingCare.pdf (8th september 2013)

3. Salonen, R. Johansson, S. Karjalainen1, T. Vahlberg, J.P. Jero and R. Isoaho. Hearing aid compliance in the elderly. J5 B-ENT. 2013(9):23-28

4. Mulrow CD, Aguilar C, Endicott JE, Tuley MR, Velez R, Charlip WS, Rhodes MC, Hill JA, DeNino LA. Quality-of- life changes and hearing impairment. A randomized trial. Ann Intern Med. 1990;113(3):188-194.

5. Mulrow CD, Tuley MR, Aguilar C. Sustained benefits of hearing aids. Journal of Speech Hearing Research. 1992;35(6):1402-140

6. Deafness and hearing impairment.[online].2010 Apr[cited 2010 sep 22] URL:http;/www.who.int/mediacentre/factsheets/fs300/en/index.html (accessed at 8th september 2013)

7. Bridget Shield. Evaluation Of The Social And Economic Costs of Hearing Impairment. A report for hear-it October 2006. available from http://www.hear- it.org/multimedia/Hear_It_Report_October_2006.pdf(accessed at September 10,2013) 8. Dhingra P L, Dhingra S, Diseases of Ear, Nose and Throat.5th edition. New delhi.(48- 51).

9. Ministry of Family and Welfare. National programme for prevention and control of deafness. Available from mohfw.nic.in/WriteReadData/l892s/8616338852nppcd.pdf . (accessed at 11th September 2013).

10. Figueras B, Edwards L, Langdon D. Executive function and language in deaf children Journal of Deaf Studies and Deaf Education, 2008, 13(3):362–377

11. Srikanth S et al Knowledge. Attitude and practices with respect to risk factors for otitis media in a rural South Indian community. International Journal of Paediatric Otorhinolaryngology, 2009, 73:1394–1398

12. Rout N et al. Risk factors of hearing impairment in Indian children: a retrospective case-file study. International Journal of Rehabilitation Research, 2008, 31(4):293–296

13. Vernon M. Fifty years of research on the intelligence of deaf and hard-of-hearing children: a review of literature and discussion of implications. Journal of Deaf Studies and Deaf Education, 2005, 10(3):225–231.

14. Yoshinaga-Itano C, Gravel JS. The evidence for universal newborn hearing screening American Journal of Audiology, 2001, 10:62–64.

15. Ruben RJ. Redefining the survival of the fittest: communication disorders in the 21st century. Laryngoscope, 2001, 110:241–245

16. Listen hear! The economic impact and cost of hearing loss in Australia. Canberra, Access Economics, 2006 (http://www audiology asn au/pdf/listenhearfinal pdf, accessed 12 september 2013)

17. Ciorba A et al. The impact of hearing loss on the quality of life of elderly adults. Clinical Intervention in Ageing, 2012, 7:159–163. 18. Jeffrey J. DiGiovanni .Hearing aid hand book. 2011, 34-43, 55-58.

19. Vuorialho A, Sorri M, Nuojua I, Muhli A. Changes in hearing aid use over the past 20 years. European Audiology of research Otorhinolaryngology 2006:263(4):355-360.

20. Kochkin S: MarkeTrak VIII: 25-Year trends in the hearing health market. Hearing Review 2009;16(10):12-31.

21. Kochkin S. MarkeTrak VIII: Patients report improved quality of life with hearing aid usage. Hearing Review. 2010;4(16):18-34,72-74.

22. Knudsen LV, Oberg M, Nielsen C, Naylor G, Kramer SE. Factors influencing help seeking, hearing aid uptake, hearing aid use and satisfaction with hearing aids: a review of the literature. Trends in Amplification. 2010;14(3):127-154.

23. Parving A, Philip B. Use and benefit of hearing aids in the tenth decade and beyond. Audiology. 1991;30(2): 61-69.

24. Jenstad, L. M. & Moon, J. (2011). Systematic review of barriers and facilitators to hearing aid uptake in older adults. Audiology Research 1(1S), e25.Doi:10.4081/audiores.2001.

25. Bentler, R.A. Kramer, S.E. Guidelines for choosing a self reported outcome measure. Ear and hearing, 2000. 21(pp37s-49s).

26. Perez E, Edmonds BA. A Systematic Review of Studies Measuring and Reporting Hearing Aid Usage in Older Adults since 1999: A Descriptive Summary of Measurement Tools. PLoS ONE 7(3): e31831. doi:10.1371/journal.pone.0031831. 2012.

27. Gatehouse S.Glasgow Hearing Aid Benefit Profile: deviation and validation of a client centered outcome measure for hearing aid services”, Journal of American Academy of Audiology.1999.10:80-103. 28. Cox RM, Stephens D, Kramer SE: Translations of the International Outcome Inventory for Hearing Aids (IOI-HA). International Journal of Audiology. 2002, 41(1):3– 26.

29. World Health Organization. WHOQOL-BREF June 1997. Available from http://depts.washington.edu/seaqol/docs/WHOQOLBREF%20with%20scoring %20instructions.pdf (accessed 24th September 2013). 9. SIGNATURE OF THE CANDIDATE:

10. REMARKS OF THE GUIDE: This study is feasible and will help in improving the quality of hearing aids and advice to the beneficiaries.

11. NAMES AND DESIGNATION Dr. DOMINIC MISQUITH Professor - Community Health

11.1 SIGNATURE OF THE GUIDE:

11.2 GUIDE: DR. DOMINIC MISQUITH Professor Department of Community Health St. John’s Medical College Bangalore-560 034 11.3 SIGNATURE OF THE CO-GUIDE:

11.4 CO-GUIDE: DR. DEEPTHI N. SHANBHAG Assistant Professor Department of Community Health St. John’s Medical College Bangalore-560 034 11.5 SIGNATURE OF THE CO-GUIDE:

11.6 CO-GUIDE: DR. RAMESH A. Associate Professor Department of ENT St. John’s Medical College Bangalore-560 034 11.7 SIGNATURE OF THE HEAD OF THE DEPARTMENT:

11.6 HEAD OF THE DEPARTMENT: DR. BOBBY JOSEPH Professor and Head Department of Community Health St. John’s Medical College Bangalore-560 034

12.1 REMARKS OF THE CHAIRMAN AND PRINCIPAL:

12.2 SIGNATURE