Original article| Volume 16, 101076, July 01, 2022

# Voice prosthesis experience of Indian laryngectomees: Preliminary findings from a tertiary hospital in South India

Open AccessPublished:May 26, 2022

## Abstract

### Introduction

Tracheoesophageal speech is a preferred method of alaryngeal voice rehabilitation in persons with a laryngectomy. Periodic replacements, troubleshooting, and stringent care are required to successfully use this device. There is a dearth of information on the perspectives of TE speakers from developing countries regarding the use and handling of this type of pseudo-voice. The current study aims to understand patient's viewpoints regarding their restored voice.

### Method

The Voice Prosthesis Questionnaire (VPQ) developed by Kazi (2006) was translated into 2 regional languages with the addition of four questions and was used in this study. The questionnaire focused on aspects related to the use and care of the prosthesis device, problems faced, management strategies used, and overall satisfaction.

### Results

The results indicated the following issues: the cost was a major concern; high tolerance for leakage; not seeking medical advice until serious complications arose; concerns about the physical distance to laryngectomy rehabilitation centers; and absence of trained professionals near their place of stay. Further, it was interesting to note the indigenous solutions for enhanced prosthetic life and humidification of inhaled air.

### Conclusion

Most participants of this study were satisfied with their restored voices as they believed that the alaryngeal mode of communication improved their quality of life. There is a need to develop indigenous humidification and hands-free speech systems that are affordable and feasible for the climatic conditions of India.

## 1. Introduction

Tracheoesophageal puncture (TEP) for alaryngeal communication offers superior voice quality and an increased mean length of utterance. A high success rate in the acquisition of “fluent” speech by TEP with Blom-Singer's voice prosthesis has been reported in the literature.
• Hazarika P.
• Murty P.S.
• Shekhar B.R.
• Kumar A.
Surgical voice restoration in alaryngeal patients. Indian.
,
• Tardy-Mitzell S.
• Andrews M.L.
• Bowman S.A.
Acceptability and intelligibility of tracheoesophageal speech.
Voice prostheses have been constantly evolving with modifications to reduce prosthesis-related complications, increase valve life and efficiency, and thereby improve user experience and quality of life. Several questionnaire studies on the quality of life and quality of voice have been reported from the west.
• Kazi R.
• Singh A.
• De Cordova J.
• et al.
Postlaryngectomy vocal rehabilitation: assessment using a validated questionnaire in 51 patients.
• Lundström E.
• Hammarberg B.
• Munck-Wikland E.
Voice handicap and health-related quality of life in laryngectomees: assessments with the use of VHI and EORTC questionnaires.
• Perry A.
• Casey E.
• Cotton S.
Quality of life after total laryngectomy: functioning, psychological well-being and self-efficacy.
The application of quality of life protocols has revealed that total laryngectomies face an impact on the social, physical, and psychological levels of functioning. Several studies have reported an improvement in voice quality after alaryngeal rehabilitation.
• Nemr K.
Scientific evidence regarding the quality of life of total laryngectomees.
Regular use of voice prosthesis is associated with improved voice intelligibility.
• Silva J.C.
Quality of life assessment in total laryngectomized patients rehabilitated with voice prosthesis.
The situation in India is comparatively different due to various factors such as low socio-economic status, illiteracy, and low accessibility to health care. In India, 0.47 million new head and neck cancer cases are diagnosed per year, which is the second most common cancer in India.
• Singh S.P.
• Eisenberg R.
• Hoffman G.
An overview and comparative evaluation of head and neck cancer risk factors in India and Australia.
Cancers frequently observed in India are lifestyle dependent, with offending factors such as tobacco usage, low socioeconomic status etc.
• Desai P.B.
Cancer control efforts in the Indian subcontinent.
Considering the low literacy rates and low socio-economic status, most cancer afflicted patients are likely to seek treatment only at advanced stages,
• Desai P.B.
Cancer control efforts in the Indian subcontinent.
despite advances in cancer diagnostics. The incidence of laryngeal cancer has been reported to be 1.26–8.18 per 100,000 population in different regions of the country (National Cancer Registry Program ICMR,2013).
There have been concerted efforts to study the acoustics of alaryngeal speech and speech with different types of prostheses. A study showed that the lungs being the air stream source for tracheoesophageal (TE) speech production, significantly contributed to the superior speech timing and speech intelligibility of the alaryngeal speakers.
• Štajner-Katušić S.
• Horga D.
• Mušura M.
• Globlek D.
Voice and speech after laryngectomy.
In a blinded study, six voice prostheses were assessed over two clinical visits for ease of swallowing.
• Coffey M.M.
• Tolley N.
• Howard D.
• Hickson M.
Double blind study investigating the effect of different voice prostheses on ease of swallowing and residue post laryngectomy.
The experts chose Blom-Singer Low pressure and Blom-Singer Classic Indwelling voice prostheses, whereas self-evaluation by patients did not lead to a single most preferred prosthesis. This study hence suggested the importance and beneﬁts of involving patients in the choice of prosthesis.
A pre-and post-comparison of quality of life (QoL) in 12 Jordanian laryngectomees
• Attieh A.Y.
• Searl J.
• Shahaltough N.H.
• Wreikat M.M.
• Lundy D.S.
Voice restoration following total laryngectomy by tracheoesophageal prosthesis: effect on patients' quality of life and voice handicap in Jordan.
showed significant improvement following successful prosthetic voice restoration as well as a reduction in voice handicap. In another study involving the quality of life of male tracheoesophageal speakers,
• Doyle P.C.
Auditory-perceptual scaling and quality of life in tracheoesophageal speakers.
the authors reported a high level of self-perceived QoL in the domains of communication. Few studies have attempted to understand TE speaker's outlook on their voice quality, prosthesis care as well as satisfaction.
• Giordano L.
• Toma S.
• Teggi R.
• et al.
Satisfaction and quality of life in laryngectomees after voice prosthesis rehabilitation.
,
• Schindler A.
• Mozzanica F.
• Ginocchio D.
• Invernizzi A.
• Peri A.
• Ottaviani F.
Voice-related quality of life in patients after total and partial laryngectomy.
There have been only a few publications in this area from India, a majority being from the perspective of clinicians and not the patients. The dearth of patient-reported information on the holistic understanding of the QoL of TE speakers in India has necessitated the current study. Detailed information on voice prosthesis experience by Indian tracheoesophageal speakers and knowledge of specific issues faced by them will be useful for voice clinicians to understand the nuances of prosthetic voice restoration in India.

## 2. Methodology

The Voice Prosthesis Questionnaire (VPQ), developed and validated by Kazi and Colleagues
• Kazi R.
• Singh A.
• De Cordova J.
• et al.
Validation of a voice prosthesis questionnaire to assess valved speech and its related issues in patients following total laryngectomy.
was used for this study. It comprises 45 questions under specific domains as follows: Device related, Speech related, Leakage related, Prosthesis Removal/replacement-related issues, Maintenance, Quality of life, Humidification issues, and Hands-free speech issues.
Prior permission for the use of VPQ was requested and obtained from its first author, following which ethical approval and clearance for the study were taken from the institutional research committee and ethical committee.
Prior to translation, three questions appropriate to the Indian scenario about factors such as the cost of the device, patient's education, and current diet were added. The factor of cost was added to understand the financial implications. The inclusion of the question on education was to probe if literacy affected the use and management of voice prostheses. The item on the diet was added to see if regular consumption of curd and buttermilk leads to reduced complaints of leakage due to fungal colonization.
The questionnaire was translated into two regional languages- Kannada and Malayalam through forward translation by four individuals proficient in English-Malayalam and four individuals proficient in English-Kannada. This was followed by back translation by four other individuals proficient in English-Malayalam and four individuals proficient in English-Kannada. Commonalities and differences in the translations were considered to retain the semantic and syntactic components in Kannada and Malayalam with reference to the original English version. These questionnaires in two regional languages were individually reviewed by five speech-language pathologists (SLPs) with a minimum of 5 years of clinical experience in laryngectomy rehabilitation, along with excellent proficiency in the target languages. Two laryngectomee individuals, one native speaker of Kannada and one native speaker of Malayalam, reviewed the questionnaire in the respective regional languages to check the understandability and readability.
The regional versions were iterated and a satisfactory version of Kannada-VPQ and Malayalam-VPQ was finalized.
TE speakers were identified through a retrospective search of medical records from the database of a tertiary teaching hospital in Manipal, located in the southern state of Karnataka, India. TE speakers with sufficient proficiency in reading and writing Kannada/Malayalam/English and who have been using tracheoesophageal speech for at least one year were included in the study. Patients with associated neurological or psychiatric problems were excluded from participation.
TE speakers who fulfilled the inclusion and exclusion criteria were contacted by telephone and information regarding the study was provided. Their oral consent was subsequently taken for participation in the research and their postal address was sought. The questionnaire in the language preferred by the participants was then posted along with a letter providing information about the purpose of the survey, a consent form with a confidentiality statement, and a return postal envelope. A reminder was given via phone call after a week.

## 3. Results

Pre-laryngectomy counseling is routinely given to all patients who are planned to undergo total laryngectomy surgery in our hospital. The various options of alaryngeal speech rehabilitation are explained and demonstrated to all patients and they are followed-up after surgery. The choice of TE speech rehabilitation is encouraged in patients who are deemed good candidates. Patients who fail to fulfill the criteria for TE speech are advised esophageal speech training or the use of an artificial larynx. However, due to lack of motivation and financial constraints, few patients opt to rely on alternative communication strategies such as writing and a combination of gestures with mouth movements.
As the aim of the current study was to understand the handling of TE speech, a retrospective search of laryngectomy patients who had visited the department of speech and hearing for TE rehabilitation during the last five years was done. A total of 27 TE speakers were traced from hospital databases and were contacted via telephone for their present status. Out of 27, six had expired, and five could not be contacted due to incorrect contact information. One patient was not using TE speech as he had enlargement of TE puncture as a complication of radiation therapy following which he developed pneumonia due to recurrent leakage issue and the puncture had to be closed.15 participants (Kannada-10, English-2, and Malayalam-3) were available for participation in the study. Patient details and responses obtained through VPQ (Kannada, Malayalam, and English) are as follows: all fifteen participants were males and their ages ranged from 62 to 80 years, with a median of 71 years. The patient demographic characteristics are mentioned in Table .1.
Table 1Patient demographic characteristics.
Number of participantsPercentage
Type of voice prosthesis currently used
Duck bill320%
Blom-Singer Low pressure746.6%
Blom-Singer Indwelling16.66%
Provox Indwelling426.6%
Years of experience using voice prosthesis
More than 10 years746.6%
Less than 10 years853.3%
Highest Educational Qualification
Up to Secondary School533.3%
Less than Secondary School746.6%

## 4. Device related issues

### 4.1 Knowledge of voice prosthesis dimensions

53% (n = 8) of participants were aware of the dimensions of their voice prosthesis whereas 47% (n = 7) did not know the dimensions.

### 4.2 Cost of voice prosthesis

93% of the patients (n = 14) regarded the cost of the voice prosthesis as “Too much”, and only one participant considered the cost “Affordable”.
Responses of TE speakers regarding the cost of voice prosthesis are depicted in Fig. 1.

### 4.3 Consumption of dairy products

For the added question on the consumption of buttermilk, eight participants reported that they consumed buttermilk “daily”; five participants reported a frequency of “2 to 3 times a week” and two participants reported that they do not consume buttermilk at all.

## 5. Speech related issues

All fifteen patients considered that their restored voice was loud enough in quiet situations (13 = “Always”, 2 = “most of the time”). However, in noisy surroundings and telephone usage, a majority of the participants felt their voice was adequately loud “most of the time”. Three patients stated they were “never” adequately loud in a noisy situation and four mentioned they were “never” loud over the phone. The rating of “Always” loud enough was given by two patients for the noisy situation and three participants for telephone usage.

### 5.2 Listener's understanding of TE speech

Most of the TE speakers felt that the listeners could understand their speech. The participant's responses are as follows: In quiet situation (13 = “Always”, 2 = “Most of the time”); In noise (2 = “Always”,10 = “Most of the time”, 3 = “Never”) and Telephone (3 = “Always”,6 = “Most of the time”, 6 = “Never”).
Responses of TE speakers for the adequacy of loudness and listener's understanding of TE speech in different situations are depicted in Fig. 2.

### 5.3 Self-perceived tone of voice

All fifteen patients perceived the pitch of their prosthetic voice as low.
Ten patients considered the pitch as “Too low” while five patients gave a rating that is indicative of “Low”.

## 6. Leakage related issues

### 6.1 Concern about leakage issues

In the domain of leakage-related issues, it was surprising to find that for most of the patients (n = 8), concern over leakage was indicated as “Not an issue”. Five patients considered leakage a “moderate issue”, while only two stated that leakage was a “major issue” for them. This finding is in synchrony with other Indian studies which have expressed that the patients in developing countries were more tolerant of issues than their western counterparts.

### 6.2 Management of leakage

A user of the duckbill voice prosthesis stated that he used a self-styled strategy to minimize through-the-prosthesis leakage; he reported that using a thread, he tied a knot around the prosthesis tip next to the esophageal flange to reduce the gaping of the slit valve and the resultant leakage. Another participant reported that he used two non-indwelling voice prostheses alternatively. He would immerse one of the prostheses in an antifungal solution for 24 h to disinfect it while using the other prosthesis, thus alternating between the two.
Another participant reported that he regularly soaked a scarf in cold water and after wringing it free of dripping water, slightly wrenched, which he tied around as a laryngeal bib to effectively function as a inexpensive, homemade humidification device.

### 6.3 Frequency of voice prosthesis change

For the question- “How often has the voice prosthesis been changed?”, the answer options were “Never” or an option to indicate the frequency of voice prosthesis change in months.
None of the participants selected the option “Never” which indicates that all participants have replaced their voice prosthesis at least once. However, the frequency of voice prosthesis replacements indicated by the participants was variable. A mean device lifetime of 14 months was obtained from the responses of all fifteen patients. The shortest lifetime reported is 2 months and the longest is 22 months.

## 7. Removal/replacement related issues

### 7.1 Reasons for replacement of voice prosthesis

Additionally, the reasons for the replacement of voice prosthesis were explored in the form of a multiple answer question, the responses are as follows: “leakage through the prosthesis” was indicated by ten participants; “leakage around the prosthesis” was reported by five participants; “no voicing” was mentioned by five participants and “effortful voicing” by one. One mentioned that the prosthesis had been cut off once and required replacement.
Patient's report on reasons for replacement of voice prosthesis is depicted in Fig. 3.
All patients reported that they used their prostheses repeatedly after cleaning until faced with some problem. Out of fifteen, nine reported that they were able to remove and reinsert the prosthesis on their own; one reported that his spouse carried out the insertion and removal. Five were users of indwelling voice prostheses and required the help of the clinician.

### 7.2 Ease of insertion and removal

Insertion and removal of voice prosthesis were rated as “too difficult” by five patients, which was expected as they were all users of the indwelling voice prosthesis. Among the non-indwelling voice prosthesis, seven patients stated that removal of the voice prosthesis was “very easy” and three gave a rating of “Manageable”. Insertion ratings were as follows: 4 = “Very easy” and 6 = “Manageable”.

## 8. Maintenance

Two participants stated that they had accidently coughed their voice prosthesis out. All fifteen stated that their voice prosthesis was easy to clean and used different methods for cleaning: both brush and pipette (n = 4); only brush (n = 6); only pipette (n = 2) and the remaining three reported that they neither used a brush nor a pipette and washed their voice prosthesis directly in running water with soap. All fifteen mentioned that they cleaned their voice prosthesis once daily.
One patient mentioned damage to the voice prosthesis (Blom- Singer low pressure) on using the cleaning brush which was provided along with the duckbill voice prosthesis that he had used earlier. Another patient reported damage to the voice prosthesis by using an inserter provided for his earlier voice prosthesis of a different type.

## 9. Questions on quality of life

### 9.1 Quality of life

Nine participants stated that voice restoration had improved their quality of life; six stated that their quality of life had not changed.
The influence of voice restoration on the quality of life is depicted in Fig. 4.

Ten out of fifteen stated that voice restoration has helped them to completely return to their activities of daily living, while five participants expressed that their prosthetic voice helped them to partially return to their daily activities.
The influence of voice restoration in returning to daily activities is depicted in Fig. 5.

### 9.3 Rating of swallowing ability

73% of participants reported their swallowing ability as “Good”, 20% described it as “excellent” and 7% rated swallowing ability as “poor”.

## 10. Humidification and hands-free speech issues

None of the fifteen participants answered the questions related to humidification and hands-free issues as none of them were using any form of humidification or hands-free systems. A few participants expressed concerns about the cost involved for the hands-free device.

## 11. Suggestions

One of the participants suggested the need for a low-cost hands-free system to thwart the strain of repeated raising of the hand to close the stoma to speak.
Another participant, complained about his voice prosthesis being pushed forward during sudden, forceful coughing. He was informed regarding the receded thickness of his tracheoesophageal party wall by his doctor. He opined that he preferred the indwelling voice prosthesis with a larger tracheal flange as it was lighter compared to the non-indwelling type.
One participant reported that he did not find the prosthesis with a large esophageal flange suitable for him as he noticed it being retracted during the attempts of swallowing solid food. Another participant reported reduced instances of through-the-prosthesis leakage after shifting from Blom-Singer duckbill to Blom-Singer low-pressure voice prosthesis.

## 12. Discussion

The present study aimed at understanding the perspectives of TE speakers on the various prosthetic aspects related to their restored voice. It was found that most of the participants were using low-pressure, non-indwelling voice prostheses. The popularity of this type of voice prosthesis can be attributed to the low-pressure prosthesis not requiring much pressure to open the valve. Further, a non-indwelling voice prosthesis reduces the patient's dependency on the clinician for cleaning and changing. Besides, the difference in the cost between non-indwelling and indwelling voice prostheses is a major driving factor in opting for it.
Most of the participants indicated that they were not using any other form of communication other than their restored voice. This endorses that the TE speech is a much relied upon and superior form of alaryngeal speech and provides an efficient mode of communication. Regarding the knowledge of the prosthesis, most participants were aware of its dimensions. Awareness of the voice prosthesis dimension is crucial for the care and maintenance of the device; the use of a cleaning brush with incorrect length may permanently damage the voice prosthesis. Therefore, treating clinicians should remember to also educate the laryngectomee regarding the dimensions of the prosthesis being used, to ensure proper care and maintenance of the same. Moreover, travel distance from the treating clinician or voice restoration clinic is a major issue in a developing country like India. Knowledge of the voice prosthesis dimension will further help procure suitable accessories via phone and prevent unnecessary travel to the treating hospital. The patient's educational level is also a factor that can facilitate better device management and subsequently improve quality of life.
• Varghese B.T.
• Mathew A.
• Sebastian P.
• Iype E.M.
• Vijay A.
Comparison of quality of life between voice rehabilitated and nonrehabilitated laryngectomies in a developing world community.
,
• Fagan J.J.
• Lentin R.
• Oyarzabal M.F.
• Isaacs S.
• Sellars S.L.
Tracheoesophageal speech in a developing world community.
The cost of the prosthesis appears to be the major problem in India, out of fifteen TEP speakers, fourteen stated that the cost of the prosthesis is high. This observation is as expected from the existing literature that the cost of the voice prosthesis is considered to be high in developing countries.
• Staffieri A.
• Mostafa B.E.
• Varghese B.T.
• et al.
Cost of tracheoesophageal prostheses in developing countries. Facing the problem from an internal perspective.
,
• Chaukar D.A.
• Vaidya A.D.
• D'Cruz A.K.
Practice of laryngectomy rehabilitation interventions: a perspective from India.
In a study by Varghese and colleagues, 2011, financial constraints were also reported to be the major reason behind some laryngectomy patients choosing to rely solely on alternative communication strategies such as gestures; in addition, costs involved in periodic replacements were a reason for discontinued use of TE speech in some patients.
• Varghese B.T.
• Mathew A.
• Sebastian P.
• Iype E.M.
• Vijay A.
Comparison of quality of life between voice rehabilitated and nonrehabilitated laryngectomies in a developing world community.
All types of alaryngeal speech differ significantly from the normal voice and speech. Acoustically, TE speech is regarded as having a lower pitch and rough quality. One of the questions in the study was to rate the self-perceived tone of voice on a 10-point scale from “Too low to Too High”, about 67% of participants stated that it was too low. Tone, being a perceptual attribute of the fundamental frequency, becomes more relevant in the characterization of voice in female TE speakers. This aspect has been discussed in an Indian study,
• Golhar S.
Tracheo oesophageal puncture voice: an Indian perspective.
in which the author observed that 30% of TE speakers disliked their voice quality and often felt it lacked sexual characterization. Since all the participants in our study were males, a low-pitched voice was considered satisfactory.
A prominent factor seen in the Indian context that is quite different from the west is the extended life span of the voice prosthesis. The mean device lifetime was 14 months in our study. This finding adds to the existing literature on device lifetime that has been reported to be significantly different in different patient groups across geographical regions.
• Hilgers F.J.M.
• Ackerstaff A.H.
• Van Rossum M.
• et al.
Clinical phase I/feasibility study of the next generation indwelling Provox voice prosthesis (Provox Vega).
The data from developing countries show a trend towards increased device lifetime as compared to the West.
• Cornu A.S.
• Vlantis A.C.
• Elliott H.
• Gregor R.T.
Voice rehabilitation after laryngectomy with the Provox® voice prosthesis in South Africa.
,
• Cruz S.
• Viana R.
• Guimarães J.
• Fernandes J.
• Silva J.C.
• Monteiro E.
Tracheoesophageal voice prosthesis outcomes: success or insucess?.
Studies from India have reported variable device lifetimes, a study by Krishnamoorthy and Khwajamohiuddin on 60 TE speakers, reported a mean device life of 16 months.
• Krishnamurthy A.
• Khwajamohiuddin S.
Analysis of factors affecting the longevity of voice prosthesis following total laryngectomy with a review of literature.
Chauker and team reported a median lifetime of 900 days for Provox indwelling patients.
• Chaukar D.A.
• Vaidya A.D.
• D'Cruz A.K.
Practice of laryngectomy rehabilitation interventions: a perspective from India.
Meanwhile, an average lifetime of 7.4 months was reported in another study from south India.
• Iype E.M.
• Janardhanan D.
• Patil S.
• Suresh S.
• Varghese B.T.
• Thomas S.
Voice rehabilitation after laryngectomy: a regional cancer centre experience and review of literature.
In the current study, out of the fifteen patients, only one reportedly used anti-fungal medication, whereas the rest did not use any of those anti-fungal colonization methods. Therefore, other factors such as dietary habits possibly have an important role to play in the longevity of the prosthesis. Increased lifetime of the voice prosthesis in Indian TE speakers may be attributed to regular consumption of buttermilk by most of the patient groups including participants of the current study. Modified dietary inclusion can go a long way in effectively reducing fungal deposits on the voice prosthesis, thereby considerably extending the device's life-time.
• Busscher H.J.
• Bruinsma G.
• Van Weissenbruch R.
• et al.
The effect of buttermilk consumption on biofilm formation on silicone rubber voice prostheses in an artificial throat.
Our findings align with other reports from India on the benefit of the inclusion of dairy products such as yoghurt and buttermilk in reducing fungal formation.
• Chaukar D.A.
• Vaidya A.D.
• D'Cruz A.K.
Practice of laryngectomy rehabilitation interventions: a perspective from India.
,
• Krishnamurthy A.
• Khwajamohiuddin S.
Analysis of factors affecting the longevity of voice prosthesis following total laryngectomy with a review of literature.
All participants reported that they used their prostheses until faced with some problems and did not do periodic replacements. Another Indian study reported similar findings, patients were reluctant for replacement and there was a tendency to tolerate minor leaks25. Most of the participants had mentioned that the distance to the hospital/rehabilitation center was a matter of concern to them. Due to a shortage of trained Speech-Language-Pathologists (SLPs)/voice clinicians/head and neck surgeons in the field of alaryngeal voice restoration at their location, they had to rely on hospitals far off from their hometowns to seek medical advice. A participant reported an instance in which his voice prosthesis was damaged as the physician in his hometown immersed the prosthesis in sterilized (hot) water. Therefore, distance also appears to be the reason for the increased tolerance of complications by the TE speakers. Sometimes, though, they try to solve problems using their innovative strategies. There is also a need for skilled SLPs to facilitate voice rehabilitation programs as the success of voice restoration also depends on patient training.
• Chaukar D.A.
• Vaidya A.D.
• D'Cruz A.K.
Practice of laryngectomy rehabilitation interventions: a perspective from India.
An in-house SLP should be mandated in all centers carrying out total laryngectomies.
The response from most of the participants indicated that the leakage was not a major issue or that it was quite tolerable. This finding aligns with another Indian study,
• Golhar S.
Tracheo oesophageal puncture voice: an Indian perspective.
where it was stated that financial constraint was a major factor for most patients and that many tolerated minor leakages and came for replacement only when the leakage became intolerable. The trend in the west is that patients are prompt in replacing the voice prosthesis as they do not tolerate even the slightest leakage as it can lead to further medical complications such as pneumonia or other chronic lower respiratory tract infections. This practice is probably feasible as the cost of a prosthesis is covered by their medical insurance. Negligence to leakage may be hazardous to the patient and may result in pneumonia if the leakage persists. The patient must be educated by the clinician to remain vigilant about any form of leakage and to seek professional help on noticing the same.
About the maintenance domain, two independent incidents of damage to the voice prostheses were reported by two participants who used inappropriately sized inserter and cleaning brush, that was provided for their earlier devices. Such findings illustrate the lack of awareness among Indian TE speakers and the need to heighten awareness by counseling regarding the proper use and care of voice prostheses, which could easily be overlooked by the clinicians.
In the current study, most of the participants reported that their restored voices have improved their quality of life. Many of them denoted that the restored voice helped them to return to their activities of daily living either fully or partially. Another study from India found that voice rehabilitated persons with laryngectomy have a significantly higher quality of life score than non-voice rehabilitated persons with laryngectomy.
• Varghese B.T.
• Mathew A.
• Sebastian P.
• Iype E.M.
• Vijay A.
Comparison of quality of life between voice rehabilitated and nonrehabilitated laryngectomies in a developing world community.
The findings from our study further endorse the existing literature on TEP being the most preferred method of alaryngeal communication.
• Attieh A.Y.
• Searl J.
• Shahaltough N.H.
• Wreikat M.M.
• Lundy D.S.
Voice restoration following total laryngectomy by tracheoesophageal prosthesis: effect on patients' quality of life and voice handicap in Jordan.
,
• Clements K.S.
• Rassekh C.H.
• Seikaly H.
• Hokanson J.A.
• Calhoun K.H.
Communication after laryngectomy: an assessment of patient satisfaction.
The questions related to humidification and handsfree speech issues were unanswered by the participants, indicating that Indian patients, by and large, do not use any such accessories. This could be due to a lack of awareness or availability of Heat and Moisture Exchange (HME) devices at an affordable cost. A similar trend was reported in a study by Chauker et al. (2013) in which they stated that HME devices are rarely used due to the additional cost.
• Chaukar D.A.
• Vaidya A.D.
• D'Cruz A.K.
Practice of laryngectomy rehabilitation interventions: a perspective from India.
Another article from India by Despande (2010) also stated that the high cost of Hands-free devices and the reoccurring cost of humidification devices are cumbersome for patients.
• Deshpande M.S.
Prosthetic voice rehabilitation after total laryngectomy.
At our facility, all laryngectomy patients are counseled regarding the importance of using a stoma cover and daily replacement of the same. One of the participants of this study mentioned the use of a slightly moist stoma cover that provides comfort to him. The increased cost of TE accessories such as HME makes them inaccessible to most patients and therefore they end up relying on self-made strategies. Evidence regarding demerits of breathing through an open stoma compromising the heat and humidification process is widely reported.
• Hilgers F.J.
• Aaronson N.K.
• Ackerstaff A.H.
• Schouwenburg Pf& Van Zandwijk N.
The influence of a heat and moisture exchanger (HME) on the respiratory symptoms after total laryngectomy.
,
• Keck T.
• Dürr J.
• Leiacker R.
• Rettinger G.
• Rozsasi A.
Tracheal climate in laryngectomees after use of a heat and moisture exchanger.
Compliant use of HME devices has medical and social advantages.
• Lorenz K.J.
• Maier H.
Pulmonary rehabilitation after total laryngectomy using a heat and moisture exchanger (HME).
Better pulmonary health status, as well as lower health costs, is reported in HME users.
• Brook I.
• Bogaardt H.
• Van As-Brooks C.
Long-term use of heat and moisture exchangers among laryngectomees: medical, social, and psychological patterns.
It is highly recommended that clinicians in India provide adequate awareness to patients regarding the benefits of using HME for better respiratory health and function.
Although the current study had a limited number of participants, it possesses several strengths. It has attempted to understand the issues in TE speech from the patient's perspective. Matters about voice, device, cost, leakage and self-devised strategies for management of leakage, etc. have been explored. Such information from an Indian context is limited in the existing literature.

## 13. Conclusion

Overall, the majority of the TE speakers who participated in this study were satisfied with their restored voice and believe that this alaryngeal mode of communication improves their quality of life, further assisting them to return to their activities of daily living. The cost involved, distance to hospital, and the dearth of trained professionals in remote areas are the key aspects of concern in India. Counseling should include even the finer details such as the use of HME devices for better pulmonary health and handsfree speech devices to improve communication effectiveness. There is a need to develop indigenous humidification and hands-free systems that are less expensive, as well as feasible to use in the climatic conditions of India. The widespread availability of clinical facilities to manage alaryngeal voice restoration even in remote areas, along with insurance coverage for the rehabilitation of patients after laryngectomy, would possibly increase the preference for TE speech among other alaryngeal options. In addition, the use of supplementary accessories by laryngectomy patients in India may also increase. Future studies involving multiple institutions and participants from different regions in India are needed to understand the overall voice prosthesis experience of TE speakers in India.
High cost is the major cause that is limiting the access and use of TE rehabilitation in India. The current need is the development of Indigenous voice prostheses and accessories. Subsequent validation and manufacturing of these devices in India would significantly bring down the cost and thereby, improve the lives of persons with a laryngectomy. Though there have been concerted efforts made in recent years such as the low-cost “AUM” voice prosthesis, with innovations such as a “one size fits all” design and biocompatible inserter are promising,
• Rao V.U.
• Chatterjee S.
AUM voice prosthesis: a $1 novel modified tracheo-esophageal voice prosthesis for total laryngectomy patients (TEP). the patients in India have limited options when choosing devices and accessories. The responsibility of improving the access to TE rehabilitation is on multiple shoulders, clinicians working with persons with laryngectomy need to step forward and collaborate with the engineering fraternity to concoct a solution to this problem, and simultaneously policymakers need to envisage and implement a provision for voice rehabilitation devices under insurance and government schemes. ## Funding The authors received no financial support for the research, authorship, and/or publication of this article. ## Declaration of competing interest The authors declare that they have no conflict of interest. ## Acknowledgment We thank Dr. Rehan Kazi for permitting us to translate and use the Voice Prosthesis Questionnaire for this study. ## References • Hazarika P. • Murty P.S. • Shekhar B.R. • Kumar A. Surgical voice restoration in alaryngeal patients. Indian. J Otolaryngol. 1990; 3: 107-111 • Tardy-Mitzell S. • Andrews M.L. • Bowman S.A. Acceptability and intelligibility of tracheoesophageal speech. Arch Otolaryngol. 1985; 1: 213-215 • Kazi R. • Singh A. • De Cordova J. • et al. Postlaryngectomy vocal rehabilitation: assessment using a validated questionnaire in 51 patients. ORL (Oto-Rhino-Laryngol) (Basel). 2007; 5: 289-294 • Lundström E. • Hammarberg B. • Munck-Wikland E. Voice handicap and health-related quality of life in laryngectomees: assessments with the use of VHI and EORTC questionnaires. Folia Phoniatrica Logop. 2009; 2: 83-92 • Perry A. • Casey E. • Cotton S. Quality of life after total laryngectomy: functioning, psychological well-being and self-efficacy. Int J Lang Commun Disord. 2015; 4: 467-475 • Nemr K. Scientific evidence regarding the quality of life of total laryngectomees. Arch Otolaryngol Rhinol. 2015; 1 (037–45) • Silva J.C. Quality of life assessment in total laryngectomized patients rehabilitated with voice prosthesis. J Otolaryngol Res. 2017; 6 • Singh S.P. • Eisenberg R. • Hoffman G. An overview and comparative evaluation of head and neck cancer risk factors in India and Australia. Int J Otolaryngol Head Neck Surg. 2018; 5: 254-267 • Desai P.B. Cancer control efforts in the Indian subcontinent. Jpn J Clin Oncol. 2002; 32 (Supplement 1): 23-26 • Štajner-Katušić S. • Horga D. • Mušura M. • Globlek D. Voice and speech after laryngectomy. Clin Linguist Phon. 2006; 20: 195-203 • Coffey M.M. • Tolley N. • Howard D. • Hickson M. Double blind study investigating the effect of different voice prostheses on ease of swallowing and residue post laryngectomy. Dysphagia. 2018; 33 ([Internet]): 616-626 • Attieh A.Y. • Searl J. • Shahaltough N.H. • Wreikat M.M. • Lundy D.S. Voice restoration following total laryngectomy by tracheoesophageal prosthesis: effect on patients' quality of life and voice handicap in Jordan. Health Qual Life Outcome. 2008; 6: 1-10 • Eadie T.L. • Doyle P.C. Auditory-perceptual scaling and quality of life in tracheoesophageal speakers. Laryngoscope. 2004; 114: 753-759 • Giordano L. • Toma S. • Teggi R. • et al. Satisfaction and quality of life in laryngectomees after voice prosthesis rehabilitation. Folia Phoniatrica Logop. 2011; 63: 231-236 • Schindler A. • Mozzanica F. • Ginocchio D. • Invernizzi A. • Peri A. • Ottaviani F. Voice-related quality of life in patients after total and partial laryngectomy. Auris Nasus Larynx. 2012; 1: 77-83 • Kazi R. • Singh A. • De Cordova J. • et al. Validation of a voice prosthesis questionnaire to assess valved speech and its related issues in patients following total laryngectomy. Clin Otolaryngol. 2006; 5: 404-410 • Varghese B.T. • Mathew A. • Sebastian P. • Iype E.M. • Vijay A. Comparison of quality of life between voice rehabilitated and nonrehabilitated laryngectomies in a developing world community. Acta Otolaryngol. 2011 Mar 1; 131: 310-315 • Fagan J.J. • Lentin R. • Oyarzabal M.F. • Isaacs S. • Sellars S.L. Tracheoesophageal speech in a developing world community. Arch Otolaryngol Head Neck Surg. 2002 Jan 1; 128: 50-53 • Staffieri A. • Mostafa B.E. • Varghese B.T. • et al. Cost of tracheoesophageal prostheses in developing countries. Facing the problem from an internal perspective. Acta Otolaryngol. 2006; 1: 4-9 • Chaukar D.A. • Vaidya A.D. • D'Cruz A.K. Practice of laryngectomy rehabilitation interventions: a perspective from India. Curr Opin Otolaryngol Head Neck Surg. 2013 Jun 1; 21: 192-198 • Golhar S. Tracheo oesophageal puncture voice: an Indian perspective. Indian J Otolaryngol Head Neck Surg. 2010; 4: 408-414 • Hilgers F.J.M. • Ackerstaff A.H. • Van Rossum M. • et al. Clinical phase I/feasibility study of the next generation indwelling Provox voice prosthesis (Provox Vega). Acta Otolaryngol. 2010; 4: 511-519 • Cornu A.S. • Vlantis A.C. • Elliott H. • Gregor R.T. Voice rehabilitation after laryngectomy with the Provox® voice prosthesis in South Africa. J Laryngol Otol. 2003 Jan; 117: 56-59 • Cruz S. • Viana R. • Guimarães J. • Fernandes J. • Silva J.C. • Monteiro E. Tracheoesophageal voice prosthesis outcomes: success or insucess?. Int J Otolaryngol Head Neck Surg. 2014 Jan 9; : 2014 • Krishnamurthy A. • Khwajamohiuddin S. Analysis of factors affecting the longevity of voice prosthesis following total laryngectomy with a review of literature. Indian J Surg Oncol. 2018 Mar; 9: 39-45 • Iype E.M. • Janardhanan D. • Patil S. • Suresh S. • Varghese B.T. • Thomas S. Voice rehabilitation after laryngectomy: a regional cancer centre experience and review of literature. Indian J Otolaryngol Head Neck Surg. 2020 Dec; 72: 518-523 • Busscher H.J. • Bruinsma G. • Van Weissenbruch R. • et al. The effect of buttermilk consumption on biofilm formation on silicone rubber voice prostheses in an artificial throat. Eur Arch Oto-Rhino-Laryngol. 1998; 8: 410-413 • Clements K.S. • Rassekh C.H. • Seikaly H. • Hokanson J.A. • Calhoun K.H. Communication after laryngectomy: an assessment of patient satisfaction. Arch Otolaryngol Neck Surg. 1997; 5: 493 • Deshpande M.S. Prosthetic voice rehabilitation after total laryngectomy. Indian J Surg Oncol. 2010 Apr; 1: 146-150 • Hilgers F.J. • Aaronson N.K. • Ackerstaff A.H. • Schouwenburg Pf& Van Zandwijk N. The influence of a heat and moisture exchanger (HME) on the respiratory symptoms after total laryngectomy. Clin Otolaryngol Allied Sci. 1991; 2: 152-156 • Keck T. • Dürr J. • Leiacker R. • Rettinger G. • Rozsasi A. Tracheal climate in laryngectomees after use of a heat and moisture exchanger. Laryngoscope. 2005; 3: 534-537 • Lorenz K.J. • Maier H. Pulmonary rehabilitation after total laryngectomy using a heat and moisture exchanger (HME). Laryngo-Rhino-Otol. 2009; 88: 513-522 • Brook I. • Bogaardt H. • Van As-Brooks C. Long-term use of heat and moisture exchangers among laryngectomees: medical, social, and psychological patterns. Ann Otol Rhinol Laryngol. 2013; 6: 358-363 • Rao V.U. • Chatterjee S. AUM voice prosthesis: a$1 novel modified tracheo-esophageal voice prosthesis for total laryngectomy patients (TEP).
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