1. The NOSI™ : an innovative prosthetic treatment option for nasal speech associated with velopharyngeal dysfunction.
Ginette Phippen DClinP, MRCSLT,
Paul Grew MIMP & Mark Richards MIMP
The Spires Cleft Centre (Oxford & Salisbury)
Salisbury Oral & Maxillofacial Lab
Salisbury
NHS Foundation Trust

2. Causes of VPD (& nasal speech)
Structural Mechanical Neurogenic Mislearning
The Spires Cleft Centre, Oxford & Salisbury

3. The Spires Cleft Centre, Oxford & Salisbury
Treatment options
Surgery (+/- speech therapy)
Clear structural defect
Speech therapy
Mislearned/compensatory sounds
Prosthetics
Surgery contraindicated
Previous unsuccessful surgery
No intervention
The Spires Cleft Centre, Oxford & Salisbury

4. Non-surgical interventions for nasal speech?
Palatal prosthetics is an option for some but requires
a high level of commitment and resources.
Could a nasal obturator offer an immediate, acceptable and low burden option for some patients?
The Spires Cleft Centre, Oxford & Salisbury

5. The Spires Cleft Centre, Oxford & Salisbury
Development process
From this……
To this……
The Spires Cleft Centre, Oxford & Salisbury

6. The Spires Cleft Centre, Oxford & Salisbury
The Idea: Phase 1 ( )
Suwaki et al (2008)case study: nasal speaking valve
Literature search: 1additional case study; Hakel et al 2004, one-way valve
Product search – nasal filters
Innovative valve design by maxillofacial technicians at Salisbury District Hospital
The Spires Cleft Centre, Oxford & Salisbury

7. Developing the idea – Phase 1 (2014-15)
Trademark application/design rights/patenting
3d printing
Prosthesis prototypes
Advice from Trust Innovation Lead
Support & Funding from Spires Board
Poster CFSGBI conference (April 2014)
Contact with medical device manufacturers
The Spires Cleft Centre, Oxford & Salisbury

8. The Spires Cleft Centre, Oxford & Salisbury
Phase 1
Progress
Challenges
Positive response to preliminary development from patients and specialist centres
Valuable feedback from patients to inform design
Support from Innovation Lead
Funding from Spires Charitable Fund for development
Interest from medical device manufacturers
Making progress with development in a busy clinical service
Provision of replacement devices
Evaluating acceptability and function
Progressing from prototype to low volume manufacture
The Spires Cleft Centre, Oxford & Salisbury

9. Developing the idea – Phase 2 (2015-16)
Field testing with 19 patients; including assessment of acceptability and effect on speech
UK cleft centres signed up to test with patients…..
Small number of devices made at SDH
Potential manufacturer/commercial partner identified
The Spires Cleft Centre, Oxford & Salisbury

10. Prototype field testing
Question:
Is the NOSI™ acceptable and functional for individuals with nasal speech associated with VPD?
The Spires Cleft Centre, Oxford & Salisbury

11. The Spires Cleft Centre, Oxford & Salisbury
Field testing
The Spires Cleft Centre, Oxford & Salisbury

12. Evaluating acceptability1.
Does your speech sound different when you use
the NOSI ?
Yes
Don’t
know No H ow
does it sound to you?
_________________________________________________________________ 2.
Are you
happy to use the
NOSI
Sometimes
ave
you
used it… at home at
school
on the phone 3.
Do you like how the
NOSI looks
Not sure 4.
Would you
tell another child
/young person
to try the NOSI?
Maybe
Is there a ny
thi
ng else you want to tell us about the NOSI
The Spires Cleft Centre, Oxford & Salisbury

13. Evaluating effect on speech
GOS.SP.ASS Perceptual rating of resonance and audible nasal emission
? Nasometry
Patient reported effect (descriptive)
The Spires Cleft Centre, Oxford & Salisbury

14. The Spires Cleft Centre, Oxford & Salisbury
Patient
Age
Diagnosis
OX or SALS
Outcome
Status A 21
TBI OX
M NOSI trial at home & speech therapy
In use B 19 C 13
22q11ds
M NOSI for use in speech therapy at school D 51
CVA E 31
Cleft Palate
M NOSI trial at home F 14
Waiting G
6.9
Non-cleft VPD
X-Small NOSI H 10
Congenital Myopathy
Bespoke NOSI, one x-small nostril I J 60
Post-surg VPD
SALS
L NOSI and palatal obturator K 65
L NOSI L 8
S NOSI M 28
M NOSI
Discontinued N
NF1
Bespoke NOSI trial at home O
4.8
Worster Drought
On hold P
4.11
Non-cleft VPD Q 52 R
L NOSI trial at home
Discontinued   S 49
The Spires Cleft Centre, Oxford & Salisbury

15. Subjective Evaluation
In Use Pt
Age
Diagnosis
OX or SALS
Outcome
Subjective Evaluation A 21
TBI OX
M NOSI trial at home & speech therapy
speech effort
? facilitated voice B 19
hypernasality
speech effort C 13
22q11ds
M NOSI for speech therapy at school
Facilitated oral consonant placement D 51
CVA E 31
Cleft Palate
M NOSI trial at home
audible nasal
emission
The Spires Cleft Centre, Oxford & Salisbury

16. The Spires Cleft Centre, Oxford & Salisbury
Waiting Pt
Age
Diagnosis
OX or SALS
Outcome
Evaluation (interim) F 14
Cleft Palate OX
M NOSI trial at home & speech therapy
 hypernasality
Facilitated oral consonant placement G
6.9
Non-cleft VPD
XS NOSI H 10
Congenital Myopathy
Bespoke NOSI, one x-small nostril
 Speech effort I
22q11ds
????? J 60
Post-surg VPD
SALS
L NOSI and palatal obturator
hypernasality
ANE K 65
L NOSI L 8
S NOSI
The Spires Cleft Centre, Oxford & Salisbury

17. Discontinued Patient Age Diagnosis OX or SALS Outcome Evaluation M 28
TBI OX
M NOSI
Not independent
Robotic surgery N 10
NF1
SALS
Bespoke NOSI trial at home
Low impact of VPI O
4.8
Worster Drought
On hold
Resistant to introduction
Try later P 8
Non-cleft VPD
S NOSI
Candidate for palatal prosthesis Q 52
Candidate for surgery R 19
L NOSI trial at home
Unhappy with appearance S 49
CVA
The Spires Cleft Centre, Oxford & Salisbury

18. The Spires Cleft Centre, Oxford & Salisbury
Next steps?
The Spires Cleft Centre, Oxford & Salisbury

19. Development process – Phase 2 (2016)
Medical technology company discussions
Prototype 2 prosthesis completed (Injection
moulding)
Further field testing with 12 patients and other
cleft centres/SLT depts
Class 1 Medical Device/CE marking
Commercialisation process
Formal evaluation
The Spires Cleft Centre, Oxford & Salisbury

20. The Spires Cleft Centre, Oxford & Salisbury
Prototype 2
The Spires Cleft Centre, Oxford & Salisbury

21. The Spires Cleft Centre, Oxford & Salisbury
Thank you
REFERENCES
Suwaki, M., Nanba, K., Ito, E., Kumakura, I.,
Minagi, S. (2008) The effect of nasal speaking
valve on the speech under experimental
incompetence condition. Journal of Oral
Rehabilitation, May, 35/5, 361-9
Hakel, M., Beukelman, D,R., Fager, S., Green, J.,Marshall, J. (2004) Nasal obturator for velopharyngeal dysfunction in dysarthria:
Technical report on a one-way valve. Journal of Medical Speech-Language Pathology, December,12/4,
Sell, D., Harding, A. & Grunwell, P. (1999). GOS.SP.ASS'98: an assessment for speech disorders associated with cleft palate and / or velopharyngeal dysfunction (revised). Int. J. Language & Communication Disorders, 34(1),
For more information
please contact:
Ginette Phippen
©NOSI™ 2014
The Spires Cleft Centre, Oxford & Salisbury